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Next Billion-Dollar Startups: Truepill’s Dose Of Digital Disruption To The $400 Billion Pharmacy Industry

I was barely getting any sleep,” Umar Afridi, cofounder and CEO of Truepill, says of the tech-enabled pharmacy company’s early days. From 9 a.m. to 4:30 p.m. each day, he worked at Truepill’s distribution center in Hayward, California. Then he drove to his job as a pharmacy manager at a 24-hour CVS in East San Jose. On the side, he studied for a dozen state pharmacy exams so that Truepill, which at the time had no other pharmacists on staff, could legally ship to those states. “It was a pretty crazy first year,” he says with characteristic understatement.

That craziness has paid off for Afridi, 37, and his cofounder, Sid Viswanathan, 35, who hope to upend the staid, heavily regulated pharmacy business with technology. Truepill, which is based in San Mateo, California, shipped its first prescriptions in 2016. Last year its revenue reached $48 million, helped by the fast growth of direct-to-consumer customers like Nurx, which sells birth control, and Hims, which focuses on remedies for hair loss, erectile dysfunction and acne. This year Truepill could double its revenue to $100 million, as it expands its customer base beyond direct-to-consumer medications to prescriptions that treat more serious illnesses.

Those revenue numbers gained Truepill a spot on Forbes’ Next Billion-Dollar Startups list this year, despite its having raised just $13 million in venture funding led by Initialized Capital at a valuation of $80 million in its last round. That valuation makes Truepill an outlier on the list, as does the fact that Afridi and Viswanathan own the majority of the business and plan to continue to do so after raising the next round of capital, expected before the year’s end.

Afridi and Viswanathan—and their investors—are betting that Truepill will see a big payoff as consumers move away from in-person doctor visits and to a new model of telemedicine. “This is the building block of digital health and the future of healthcare,” says Initialized managing partner Garry Tan.

Pharmacy is a roughly $400 billion business in the United States, yet only recently have entrepreneurs begun tackling the market. In 2013, two young founders launched PillPack, a retail pharmacy startup that was acquired by Amazon last year for around $750 million. Other newcomers followed, including New York City’s Capsule, which grabbed $270 million in funding to do same-day prescription delivery refilled via text.

Truepill’s difference: Its business-to-business model makes it a behind-the-scenes player, invisible to retail customers, who will never have reason to know its name. That’s by design, and it allows Truepill to sign agreements with drugmakers and pharmacy benefit managers, those industry intermediaries that sit between insurers and drugmakers, without directly competing with them. “We’re not a traditional mail-order pharmacy,” Afridi says. “We’re way more than that.”

Afridi was born in Salt Lake City and grew up in Manchester, England, where his mother’s family was from. He studied pharmacy at the University of Manchester and worked as a relief pharmacist, filling in for those who went on vacation, in England. After passing the tests to practice in the United States, he took a job at Fred Meyer near Seattle. Unlike the typical pharmacist, Afridi always had an entrepreneurial side gig. During college, he imported performance cars, like the Mazda RX-7 and the Mitsubishi Evo 5, from Japan and sold them at a profit.

                              

While working as a pharmacist, he taught himself computer programming and began playing around with the idea of an on-demand pharmacy. His goal: to ease customers’ frustrations with waiting in line to pick up medications and to cut back the phone calls and faxes required for pharmacists to do their job. “I’ve always had a passion for technology, and every time I see a problem, I think, ‘How can technology fix this?’” he says.

Viswanathan, an Indian immigrant, had worked at Johnson & Johnson, then cofounded CardMunch, a business-card scanning app. In 2011, LinkedIn bought the startup for a reported $3 million. Viswanathan stayed at the larger company after the deal, and when LinkedIn went public the stock he owned made him wealthy for the first time. “It was fairly life-changing coming from no money to having some,” he recalls. After nearly four years at LinkedIn, he was ready to leave and work on another startup. “My only criterion was what do I want to spend the next 10 years of my life on,” he says.

While he was pondering what to do next, he stumbled upon Afridi’s profile on LinkedIn—where Afridi had changed his header to “startup founder, pharmacist”—and messaged him cold to talk about healthcare. Soon the two were meeting regularly and brainstorming ideas for a business to start together.

By then, other startup pharmacies, like PillPack, were making inroads with retail customers. Rather than compete in what had become a crowded space vying for retail customers, Afridi and Viswanathan figured they could operate in the background, using technology to build an extremely efficient pharmacy distribution center. “Truepill is what you get when you put together a pharmacist and a software engineer,” Viswanathan says.

“This is the building block of digital health and the future of healthcare,” says Initialized Capital’s Garry Tan.

Their idea coincided with the rise of new direct-to-consumer health brands that needed a distributor that could follow all the pharmacy regulations. To consumers, these Instagrammable health products don’t look like drugs, and often their subscription boxes contain a mix of both prescription and over-the-counter products. But if there’s even one vial of prescription pills going out in the mail, the startup sending it needs a pharmacy to fulfill the order. In talking with Nurx, Viswanathan says, “we came to find out they were literally picking up the phone to mom-and-pop pharmacies in different states.” They gained a customer by offering a better way.

In 2017, Andrew Dudum cofounded Hims, the fast-growing direct-to-consumer therapeutics startup for men, and he, too, signed up with Truepill. “We knew from the beginning we were going to grow very fast,” Dudum says. “We expected 30 to 50 orders per day, and that was the scale we communicated to Umar and Sid that we needed to be prepared for. In the first week, we were getting 500 orders per day.” Today, Hims, which is valued at $1.1 billion, does thousands of orders per day and is one of Truepill’s largest customers. “They figured out a way to scale with us,” Dudum says.

At Truepill’s Hayward distribution center, all orders come in electronically. When Hims sends a prescription for finasteride, the male hair-loss treatment, for example, it goes through electronic vetting and then a robotic machine pulls the 1-milligram tablets from custom-made 1,000-count bottles into a small pill vial that gets labeled with Hims branding. That automation allows Truepill to work more efficiently than a traditional retail pharmacy. So, too, does its focus on a small number of medications: Ten medications, including finasteride and the erectile-dysfunction drug sildenafil, represent 80% of its volume. Its scale in those allows Truepill to turn over its inventory every few days and gives it the power to negotiate prices with drug manufacturers and pharmacy benefit managers on those products.

“Truepill is what you get when you put together a pharmacist and a software engineer,” says cofounder Sid Viswanathan.

For Afridi and Viswanathan, direct-to-consumer medications are just the beginning. They are starting to sign agreements with drugmakers and pharmacy benefit managers, though they won’t name those larger partners yet. This shift comes none too soon, as Hims has announced that it would open its own pharmacy in Ohio to shift a portion of its distribution in-house—a move that Viswanathan says will begin to impact Truepill in 2021. “Hims is a large part of the business in quantity, but not in revenue,” he says, noting that medications reimbursed by insurance are higher cost than lifestyle meds that consumers pay for out of pocket. Truepill currently has two distribution centers and is adding another five.

Afridi and Viswanathan’s next step: building a nationwide network of doctors in every state that will enable their pharmacy startup to play a bigger role in the shift to telemedicine. Those doctors will allow it to work directly with makers of specialty medications, say, so that they can distribute their medications to consumers more easily. Over time, Truepill figures its orders could rise from 5,000 to 10,000 per day to 100,000.

“Lifestyle and ED [erectile dysfunction] medications have allowed us to build the infrastructure to all these other areas,” Afridi says. “There is a lot of innovation that needs to happen in the space.”

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I’m a senior editor at Forbes, where I cover manufacturing, industrial innovation and consumer products. I previously spent two years on the Forbes’ Entrepreneurs team. It’s my second stint here: I learned the ropes of business journalism under Forbes legendary editor Jim Michaels in the 1990s. Before rejoining, I was a senior writer or staff writer at BusinessWeek, Money and the New York Daily News. My work has also appeared in Barron’s, Inc., the New York Times and numerous other publications. I’m based in New York, but my family is from Pittsburgh—and I love stories that get me out into the industrial heartland. Ping me with ideas, or follow me on Twitter @amyfeldman.

Source: Next Billion-Dollar Startups: Truepill’s Dose Of Digital Disruption To The $400 Billion Pharmacy Industry

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Hi, I’m Garry Tan, venture capitalist and cofounder at Initialized Capital. We were earliest investors in billion dollar startups like Coinbase and Instacart, and we’re spending time with some of our best founders to learn the secrets of their success and see the future they’re building. Today I sat down with Sid Viswanathan, cofounder of Truepill, an API for all needs for telemedicine. Telemedicine has the potential to bring down costs and make high quality care more accessible for every person on the planet. We’re headed to Hayward, California, their west coast HQ and fulfillment center out of which they provide pharmacy services for dozens of telemedicine startups and practices large and small, shipping to all 50 states. Come learn about how as a founder, you need to choose a problem space that you could want to work on for 10 years or more. Please like this video and subscribe to my channel if you want to see more videos like this with top founders. Find Sid on Twitter at https://twitter.com/sidviswanathan Find Garry on Twitter at https://twitter.com/garrytan Learn more about Truepill at https://truepill.com Learn more about the companies we fund, and how we work with them at https://initialized.com

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The Health Risks of Supplements & Alternative Medicine

A few weeks ago, a patient came to me complaining of nausea, muscle weakness and fatigue. Her urine was tea-colored despite drinking loads of water. A middle-aged woman, she seemed worried she had cancer or some deadly disease. Her lab tests revealed significant liver dysfunction. But her symptoms were not due to liver cancer, hepatitis or other disease. It turned out she had liver toxicity from a green tea supplement that she’d heard was a “natural” way to lose weight.

When she stopped taking the supplement at my suggestion, her liver tests gradually normalized and she felt better over the course of a few weeks

I’ve seen the green tea issue in patients before and often witness the real-life pitfalls of eschewing traditional medicine, science and facts in favor of supplements, herbs and cleanses in the name of “natural” healing.

In an effort to be healthy, patients can easily become ensnared in the potential dangers of alternative medicine or homeopathy.

Let’s be clear: Nature has a lot to offer patients.

The Greek physician Hippocrates is said to have reported on the use of St. Johnswort, a flowering plant, for mood disturbances in the 5th century B.C. Digoxin, a well-studied medicine used to treat heart failure, is derived from the foxglove plant. Parkinson’s patients are often commonly treated with the medication L-dopa, which comes from the plant Mucuna pruriens. Moreover, research repeatedly shows that consuming fruits and vegetables, getting adequate sleep and regular exercise, and spending time outdoors have myriad health benefits.

But nature isn’t always so well-intended.

Spoiler alert: Arsenic, cyanide, asbestos and snake venom derive from nature. Refined sugar, a naturally occurring substance and one that lives in most Americans’ pantries, is in large part responsible for our country’s obesity epidemic. Simply because a substance comes from nature does not mean it is good for us.

An important key to health is using nature appropriately.

And in the case of my patient, she was able to lose weight when we made a clear plan to alter her basic human behaviors. Before she started taking the green tea extract, she was skipping breakfast, drinking the equivalent of two Venti coffees before noon, eating takeout meals for lunch, washing down her late-night dinner with two glasses of wine, sleeping restlessly, and spending too much time sitting and indoors.

Green tea extract was never going to be the quick fix that she — and other patients I have seen — had hoped. It may be attractive as a natural cure for extra body fat, but this promise has not been shown in any studies, according to the National Center for Complementary and Integrative Health at the National Institutes of Health. The key to helping my patient was pretty basic: looking at her lifestyle, her stress, and creating some structure and accountability for important lifestyle changes.

While she wasn’t able to eat like Gwyneth Paltrow would recommend (who can eat Pinterest-perfect meals like that as a mere mortal?), my patient took my advice to heart that she begin eating breakfast, packing healthy leftovers for lunch at work, cutting back the wine to weekends only, and getting more exercise on weekends.

As a result, she started sleeping better and feeling more energetic. Eventually, the weight started coming off, too.

Particular patients seem to be more susceptible to the lure of “naturopathic” medicine or homeopathy. Patients who have vague symptoms that do not fit tidily into a box, for example, are often the ones combing the Internet for answers to their health woes and spending hundreds of dollars on unproven and insufficiently regulated supplements and herbs.

According to the 2012 National Health Interview Survey (NHIS), which included a comprehensive poll on the use of complementary health approaches by Americans, 17.7 percent of American adults had used a dietary supplement other than vitamins and minerals in the past year. That number is probably larger now: The total sales of herbal and dietary supplements in the United States were estimated to be more than $8 billion in 2017, the 15th consecutive year of sales growth, according to a market research report. And women were more likely than men to use these products — as well as people with more education.

Scientific data is often not the reason patients are drawn to herbal or “natural” supplements, Harvard School of Public Health researchers said. Of supplements users surveyed in 2001, 72 percent said they would continue using supplements despite a negative government scientific study. Patients reported getting much information about herbs from family, friends, advertisements and the Internet.

My patients often consider herbal remedies to be free of side effects, but many “natural” products can lead to toxicity and can dangerously interact with prescription medications.

Compounding the problem is that herbal and dietary supplements are not subject to the same strict regulatory standards as prescription drugs. On it’s website, NIH’s Office of Dietary Supplements says the products “are not required to be reviewed by the FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans.”

Last year, another patient came in to see me complaining of fatigue, joint pains and abdominal bloating. She had seen a naturopath for these symptoms, who told her she had “chronic Lyme” disease and gave her multiple rounds of antibiotics and a bag full of daily herbal supplements. She said she didn’t feel any better.

When we met, she told me she was certain she had Lyme disease that wasn’t being adequately treated. In fact, the antibiotics she had been given had only worsened her abdominal issues and caused a new problem: an intestinal infection that causes bad diarrhea.

After 10 days of appropriate antibiotic treatment, her diarrhea was gone but she was back to her tired and achy self. At my recommendation, she stopped the supplements, and her fatigue abated somewhat.

When we discussed her situation further, she revealed to me she suffered from a love-hate relationship with sugar.

Like many of my patients, when she was stressed out she binged on sugar. For most people, ingesting sugar provides a quick hit of the pleasure hormone dopamine, and for some people that rush of dopamine and the accompanying instantaneous boost of energy can become addicting.

The problem is that a high sugar load causes a surge in the hormone insulin, which then results in a sudden drop in blood sugar — which can promote fatigue, weakness and irritability, among other symptoms. If consumed in excess over time, such dietary sugar can cause abdominal distress, bloating and joint aches. This is what was probably causing my patient’s symptoms.

So we made a plan for her to not only cut back on sugar but also fill her diet with healthy stuff to get ahead of hunger and avoid binges. I also recommended she work with a therapist to deal with stress-eating. Her joint aches went away and her energy improved after about two weeks, and she continues to see a therapist for stress-eating issues.

Food — and added support to use it properly — was the fix.

Symptoms such as fatigue, headaches, joint pains and irregular bowel movements are some of the most common complaints I see in my office. They can be challenging for physicians to figure out, largely because they require careful and attentive listening by the doctor.

And since more than 40 percent of patients do not tell their doctors about their use of complementary or alternative medicine (including 25 percent who take supplements and/or herbs), physicians can be bewildered when trying to pin down a root cause for a patient’s complaints. Indeed, these patients are not easily diagnosed after a single lab test — and they are not easily fixed with a supplement.

Occasionally, it takes time with the patient, careful attention to the patient’s story, and asking the right questions to get to the bottom of the problem. Often, the solution is right under our nose.

Nature is indeed wonderful, but it doesn’t always come in a pill.

Lucy McBride is an internist based in the District.

Source: The health risks of supplements and alternative medicine – The Washington Post

John Oliver outlines what, exactly is problematic about Dr. Oz and the nutrition supplement industry. Then he invites George R.R. Martin, Steve Buscemi, the Black and Gold Marching Elite, and some fake real housewives on the show to illustrate how to pander to an audience without hurting anyone. Connect with Last Week Tonight online… Subscribe to the Last Week Tonight YouTube channel for more almost news as it almost happens: www.youtube.com/user/LastWeekTonight Find Last Week Tonight on Facebook like your mom would: http://Facebook.com/LastWeekTonight Follow us on Twitter for news about jokes and jokes about news: http://Twitter.com/LastWeekTonight Visit our official site for all that other stuff at once: http://www.hbo.com/last-week-tonight-…

How Serial Entrepreneur Keith McCarty Is Building Tech Solutions For The Cannabis Industry

Keith McCarty was two years into his Snoop Dogg-backed cannabis startup when he knew it was time for a change. Eaze, nicknamed the Uber for Weed as it serves as a delivery platform connecting cannabis dispensaries and their customers in legalized areas, was hitting its stride. It was 2014, and the company was on the eve of closing on a $40 million Series B round. What’s more, Eaze’s home state of California had just voted to legalize recreational use of marijuana, serendipitously expanding the company’s services beyond medical use clientele. But connecting clients and dispensaries came with multiplying constraints of the scattered commercial supply chain. So for McCarty, it was time to go.

McCarty, a serial entrepreneur, a founding team member of social media startup Yammer, saw an opportunity in the excruciating pain points between cannabis brands and dispensaries. In August, three years after his departure from Eaze and with $5 million in seed funding, McCarty launched Wayv, a B2B version of Eaze.“With more legalization comes more regulation and causes more friction in the supply chain,” McCarty told Forbes. That’s why he’s doubling down on his bet that tech solutions will help smooth out the logistical kinks through Wayv’s Amazon fulfillment model, in which brands can list their products and retailers can place bulk orders for next day delivery.

Like soda or cigarettes, the cannabis business is emerging with multiple brands, and each has its fans. It’s in the interest of every dispensary to carry the brands its customers prefer, but because of byzantine and contradictory state and federal laws, outlets can’t order multiple brands from a single outlet. Adding to the complication is the fact that nobody in the supply chain, not the growers, processors, distributors or retailers, can use banks to make it all happen as facilitating the sale of cannabis is against federal law.

Each cannabis brand begins with growers, processors and state-mandated laboratory tests before it hits the distributor, which gets the brand product to the warehouse before it’s ready to hit dispensary shelves. Together, cannabis brands bear the operational brunt of marketing, sales and processing transactions, and retailers can’t buy brands in bulk but have to deal with each individually.

“Today, the process retailers have to go through is sending emails, text messages and make calls to 30 to 50 brands to even place the order,” McCarty said. “This is one of the biggest white spaces in the industry and one of the most unsolved aspects.” In California, Wayv is greasing the cannabis distribution track, offering a “seed to sale” e-commerce compliance and distribution platform. For 80% of California’s licensed retailers using Wayv’s services, access to live inventory and brands beyond their geographical market means consistent and diverse product selection for dispensary customers. For a 15% fee, Wayv replaces the door-to-door salesman model for brands to get their products on store shelves and offloads the delivery and payment exchange—which is mainly cash-based.

Beboe, a high-end vape and edibles company, uses Wayv as a marketing tool and credits the platform for an uptick in sales. “Last year there was such a supply and demand issue because there was no data before,” said Kiana Anvaripour, Beboe’s VP of marketing. “Wayv has helped us be nimble and quick—it’s a way for you to be able to show your brand digitally.”

Brands, retailers and the distributor can all track the status of the order through Wayv’s platform and app, which helps avoid unwanted issues such as ordering the wrong product or amount—cannabis products legally come with a nonreturnable policy upon delivery.

Wayv also addresses one of the biggest pain points for brands, the inability to access  traditional lines of credit. To alleviate the cash flow part of the supply chain, Wayv offers an initial credit line and takes on delinquency and default for brands to help them keep up with market demand. “We understand that brands don’t want to be a distributor or tech company. Both of those are provided for a 15% fee, and that’s lower than your fully weighted distribution cost,” McCarty said.

McCarty remains the majority shareholder of Eaze, which he launched with his Yammer cofounders, Jim Patterson, Aleksey Klempner and Roie Edery. He spent a year at Microsoft after it purchased Yammer for $1.2 billion in 2012 before moving into cannabis. As research, McCarty interviewed 150 medical marijuana patients at the San Francisco medical dispensary Sparc. The biggest problem with the plant, McCarty cleared, was lack of easy access. Hence, Eaze.

“Eaze was pushing the limits of what’s required by brands to be able to participate, and very quickly you start to realize there’s a supply constraint about to happen,” said McCarty. He reemerged on the cannatech scene last summer with the launch of Wayv and $5 million in seed funding from Yammer cofounder David Sacks, his first investment in a cannabis business.

While there are a handful of cannabis POS startups, one thing Wayv has over one of its competitors is partnerships with a licensed distributor and lab. McCarty says one of the biggest hurdles brands face is getting their product into the dispensaries. The average mom-and-pop brownie business doesn’t have the funds to hire a delivery driver, so Wayv deploys a third-party distributor, Indus, to fulfill pickups for brands and drop-offs for retailers. Wayv also offers the option to offload state-mandated testing requirements by partnering with a licensed lab that conducts product batch testing adjacent to Indus’ warehouse.

Because Wayv is not vertically integrated, it’ll be easy to expand outside of California, but McCarty cautions that scaling is a race against time. “This is a very complex part of the supply chain,” he says. “People could probably do it over time, but the industry doesn’t have time.”

Follow Samar on Twitter at @HellaSamar or email her at smarwan[at]forbes.com.

Samar Marwan is the West Coast-based assistant editor of technology at Forbes. Marwan’s coverage of women run startups and the MENA tech scene has gone into defining

Source: How Serial Entrepreneur Keith McCarty Is Building Tech Solutions For The Cannabis Industry

Cannabis Companies Struggle To Become More Sustainable

Despite the bad press millennials receive, as a cohort they have committed to sustainability. A full 70% of millennials will pay more for products made sustainably, while 83% consider a product’s environmental or social impact before making a purchase. They are bringing that sense of responsibility for maintaining a livable planet to the cannabis industry which is populated with young, progressive entrepreneurs. But while cannabis is a business based around agriculture, there aren’t clear rules for how to make it more sustainable…..

Source: Cannabis Companies Struggle To Become More Sustainable

The Global Drug Industry Putting Your Life At Risk – Srinath Perur

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In late 2012, 60 people died in two cities in Pakistan after drinking cough syrup to get high. Syrups from two separate manufacturers were involved. It was found that both were using an active ingredient — dextromethorphan, a synthetic morphine-like compound — imported from the same manufacturer in India. Indian drug authorities put a halt to production while they investigated. Tests in Pakistan revealed that the medicines seemed to contain the correct amount of active ingredient. But further tests revealed something that was not supposed to be there……..

Read more: http://digg.com/2018/fake-drugs-global-industry

 

 

 

 

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Are Supplements Safe & Do They Work – Dr Carter

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The story of a man who ended up needing a liver transplant after taking green tea capsules has brought the topic of dietary supplements back into the news. What are some of the dangers of supplements and what are the health benefits? When Jim McCants started taking green tea pills he had hoped he was giving his health a shot in the arm. Instead, it appears the pills caused such serious damage to his liver that it required an urgent transplant……..

Read more: https://www.bbc.com/news/health-45992725

 

 

 

 

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Marijuana Madness: This Is How CBD Oil Can Cause A Failed Drug Test – Mike Adams

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Cannabidiol, otherwise referred to as CBD is considered by a growing number of Americans to be the best thing since sliced bread. Not only does this non-intoxicating component of the cannabis plant provide people with relief from conditions ranging from anxiety to chronic pain, but it’s also mostly overlooked by law enforcement, in spite of its outlaw status in the eyes of the federal government. But people are being told that they can consume CBD on a daily basis and never have to worry about failing a drug test……

Read more: https://www.forbes.com/sites/mikeadams/2018/10/18/marijuana-madness-this-is-how-cbd-oil-can-cause-a-failed-drug-test/#1f76c92713bb

 

 

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Antibiotic Resistance: Breakthrough Study Offers Solution – Catharine Paddock PhD

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When a team at Case Western Reserve University School of Medicine in Cleveland, OH, treated mice with specific small molecules that stop bacteria from producing toxins, all the animals survived an MRSA sepsis infection, compared with less than a third of untreated mice. The finding is significant because if the same is true of humans, then it shows that it may not be necessary to use antibiotics to cure sepsis……

Read more: https://www.medicalnewstoday.com/articles/323388.php

 

 

 

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FDA Expands Recall Of Blood Pressure Drug Valsartan Due To Cancer Concern — CBS Atlanta

Valsartan recall: 4 things patients should know By Jacqueline Howard, CNN (CNN) — Several common drugs that contain valsartan, used to treat high blood pressure and heart failure, have been recalled in the United States due to an “impurity” in the drug that poses a potential cancer risk. That impurity, N-nitrosodimethylamine or NDMA, is classified…

via FDA Expands Recall Of Blood Pressure Drug Valsartan Due To Cancer Concern — CBS Atlanta

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No Scientific Evidence That Probiotics Improve Anxiety Symptoms In Humans, Finds Study – David DiSalvo

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A new review and analysis of several studies has found that probiotics do not improve self-reported anxiety symptoms in humans, although there was evidence of minor improvements in rodents.

The study reviewed 36 preclinical studies in total, 14 involving humans and 22 involving rats and mice. That’s a decent-sized sampling of the research covering a variety of probiotic strains, and it turned up zero evidence that humans with self-reported anxiety symptoms benefited from taking any of them.

“Probiotics did not significantly reduce symptoms of anxiety in humans and did not differentially affect clinical and healthy human samples,” the study concluded.

One of the strains, Lactobacillus (L.) rhamnosus, did appear to reduce anxiety symptoms in rodents, but further analysis showed that effects were most pronounced only for the sickest of the specimens, and even in those animals the results weren’t dramatic.

Probiotics are one of the strongest selling nutritional products in the world, with annual US sales exceeding $3.3 billion in 2016. That market size is predicted to more than double by 2025. Clearly a large chunk of the supplement-buying public has confidence in these products, and the marketing push is only intensifying. But this study, like others turning up similar findings, suggests caution is warranted.

“I think people should wait — that’s the best takeaway here,” said lead study author Daniel J. Reis, a doctoral student of clinical psychology at the University of Kansas. “We’re in the early days of this research into probiotics. I’ve seen a lot of stories hyping probiotics as helpful for anxiety. We’re not saying they do nothing, but we have a lot to figure out before we know if they can be used therapeutically.”

Why some effects were found in rodents and not in humans isn’t clear, but the researchers noted that the differences in dosage between humans and rodents were significant.

“If you control for the weights of animals versus humans, animals are getting much larger doses of probiotics in these experiments by one or two orders of magnitude. Sometimes the doses were hundreds of times higher than we see in human studies,” said Reis in a press statment.

The researchers also noted that while this study didn’t find anxiety-reducing benefits for humans, it’s still possible that a pathway exists for certain strains to yield therapeutic effects. And they were clear that the anxiety levels among the human participants in the reviewed studies weren’t necessarily “clinically elevated.” Future research has an opportunity to delve more deeply among that expanding population.

“We see a lot of pathways between our digestive systems and our brains,” Reis said. “We see nervous system connections, the inflammation response — these microorganisms seem to be able to influence the human brain through this gut-brain axis. We wanted to know if changes to the microbiota could improve mental health. But in terms of research, it’s all at a very preliminary stage.”

And that, for the moment, is the big takeaway on probiotics – the research is still very preliminary, despite marketing claims of conclusive results. Evidence supporting the claims just isn’t there, at least not yet.

Scientific research is nearing a consensus that bacteria in our digestive systems affect our brains. The microbiome in our guts, populated by billions of bacteria, appears to play a significant role not only in our digestive health, but also our mental health. Exactly how this happens is still being worked out, with each new study turning over another proverbial rock of possibilities. Despite these advances, we don’t yet know how, or if, probiotic supplements can improve our mental health by influencing gut bacteria. The marketing of these products is far ahead of the facts, as a quick review of what we know will show.

First, a brief sampling of the latest bacteria-brain research, which includes a study that found specific hormonal exchanges enabling communication between gut bacteria and the brain. This is especially noteworthy because the hormone in question is cortisol, the so-called “stress hormone”– a well-established indicator of stress levels in humans and other mammals. The study was conducted in pigs, which share several physiological similarities with humans, and it identified a possible communication pathway between gut bacteria and the brain that uses cortisol as a channel to send “messages.” The implications of this research will take some time to unravel, but one initial takeaway is that our stress-response system may play a key role in how gut bacteria communicate with the brain.

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Another recent study suggests that gut bacteria may influence anxiety and depression. This study was conducted with mice raised in a sterile, germ-free environment devoid of bacterial influence. Researchers exposed these mice to gut bacteria and watched what happened compared to mice that were raised in a normal, germy environment.  The germ-free mice exposed to bacteria developed anxiety and depression symptoms on par with the human equivalent. The researchers identified a specific brain region influenced by the bacteria, and suspect that our early-life exposure to bacteria may predispose us one way or another to anxiety and depression later on. Again, the conclusions are speculative, but the research is exciting because it moves us a little closer to figuring out what’s going on.

More studies like these are underway and another wave is in the planning phase. So why, with all of this research, can’t we make grand claims for the promise of probiotics? After all, if we have even an inkling that gut bacteria affect our brains (and we certainly have more than an inkling at this point) then why not jump onboard the probiotic supplement express?

The reasons can be boiled down to a few big ones.

The probiotic philosophy is to blast the gut with billions of allegedly “good” bacteria, in hopes of populating out the bad ones. While re-populating the gut with good bacteria sounds plausible, there’s little scientific clarity around which gut bacteria are objectively “good” or if that qualification is even valid. Bacteria can be “good” or “bad” depending on a slew of variables. Even less clear is which bacteria influence the brain and how they’re exerting their influence.

But let’s say we could achieve perfect clarity on that point, there’s still an enormous gastric obstacle ahead. Whether you’re ingesting a probiotic with one billion or 30 billion live bacterial cultures, they still have to survive your stomach acid to do anything worthwhile. Only a couple types of bacteria have proven resistant enough to survive that peril (lactobacillus and bifidobacteria), which means almost everything else in your pricey probiotic capsule is toast.

But let’s say that problem is solved by a fantastic pill coating – what will this army of bacteria do once they arrive in your gut?  We simply don’t know enough to know for sure. Last year a review of probiotic trials in humans concluded that the research “demonstrates a lack of evidence for an impact of probiotics on fecal microbiota composition in healthy adults.” In other words, we don’t know precisely what probiotics are doing in the gut – and there’s at least a possibility that they aren’t doing much to make a difference.

Given how little we understand about what probiotics can accomplish in our guts, jumping to a further conclusion that they can improve our mental health is really reaching. That hasn’t stopped those marketing these products from making outlandish claims, but that’s standard operating procedure for a large chunk of supplement marketing.

Where actual science is concerned, we don’t yet know if probiotics can achieve the promises made for them, or what sort of probiotic formula will prove effective. We may eventually find out that probiotics need to be tailored to a given person’s microbiome like bespoke clothing. Once that’s established (if it can be established), then perhaps we’ll have a better opportunity to understand how probiotics might improve our mental health – assuming the underlying theory holds up over time.

Right now, we don’t know enough to justify the claims made for probiotic supplements. The marketing is leagues ahead of the evidence, and we’d do well to view these claims with skepticism. Perhaps one day probiotics will give our brains a boost, but we’re just not there yet.

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