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BOSTON and CARLSBAD, Calif., May 07, 2019 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), announced today that WAYLIVRA has received conditional marketing authorization from the European Commission (EC) as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
This authorization follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Click here to view the EC’s decision. As part of the conditional marketing authorization, Akcea and Ionis will conduct a non-interventional post-authorization safety study (PASS) based on a Registry.
“WAYLIVRA is the only approved treatment for people with FCS and is a major milestone for the global FCS community. This also marks Akcea’s second drug approval in the last year. We are very grateful to all the patients and physicians around the world who participated in our clinical trials. Their insights about the challenges of this devastating disease and their stories of how they have benefited from WAYLIVRA continue to motivate us,” said Paula Soteropoulos, chief executive officer of Akcea Therapeutics. “We plan to launch WAYLIVRA in Germany this year followed by additional European countries in 2020. Our team is ready to deliver this treatment option to patients with FCS.”
FCS is an ultra-rare debilitating disease that can be life-altering. It is caused by impaired function of the enzyme, lipoprotein lipase (LPL), which results in significant risk and disease burden, including unpredictable and potentially fatal acute pancreatitis as well as chronic complications due to permanent organ damage. It is estimated that there are between 3,000 to 5,000 people living with FCS worldwide, with approximately 1,000 people living with FCS in Europe.
“WAYLIVRA is the only treatment available for patients with FCS which makes this approval a landmark event for the global FCS community. Patients, their caretakers and their families have been suffering without any therapeutic option. Now patients across Europe can access a medicine that may help address their severely elevated triglycerides which can give them hope for better health. High triglycerides can lead to a multitude of severe and daily chronic symptoms such as abdominal pain and increased risk of pancreatitis which have a significant daily impact on people living with FCS,” said Jules Payne, chief executive at HEART UK and chair of FH Europe.
WAYLIVRA is an antisense oligonucleotide drug designed by Ionis and co-developed by Akcea and Ionis to reduce the production of ApoC-III, a protein that regulates plasma triglycerides. WAYLIVRA is a self-administered, subcutaneous injection in a single-use, prefilled syringe.
“The approval of WAYLIVRA is truly an important moment for people affected by FCS and for all of us in medicine who specialize in treating lipid disorders,” said Dr. Eric Bruckert, head of the endocrinology and prevention of cardiovascular disease department in Pitié-Salpêtrière Hospital in Paris, France. “Many clinicians are pleased to now have a treatment option available because of the significant burden of FCS on patients and their families.”
“WAYLIVRA is Ionis’ third medicine approved in just over two years. Our highly efficient and productive antisense technology has the potential to treat the untreatable by precisely targeting the root cause of disease. FCS is an example of a disease that our novel technology is ideally suited to address,” said Brett P. Monia, chief operating officer at Ionis. “We are confident that our affiliate, Akcea, has built an expert team that is committed and ready to deliver WAYLIVRA to patients as soon as possible.”
The EC’s marketing authorization of WAYLIVRA is based on results from the Phase 3 APPROACH study and the ongoing APPROACH Open Label Extension study and is supported by results from the Phase 3 COMPASS study. Results from the APPROACH trial, the largest study ever conducted in patients with FCS, show that in comparison to placebo treatment with WAYLIVRA delivered clinically and statistically meaningful reduction in triglycerides over the study period. An analysis of patients with a history of recurrent pancreatitis events (≥ 2 events in the five years prior to Study Day 1) showed a significant reduction in pancreatitis attacks in WAYLIVRA-treated patients compared to placebo treated patients. The most common adverse events in the APPROACH study were injection site reactions and reductions in platelet levels. In addition to the open label extension study, there are also ongoing global Early Access Programs for WAYLIVRA.
For important safety information for WAYLIVRA, including method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics (SmPC), which will be available on the EMA website at www.ema.europa.eu.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
About WAYLIVRA® (volanesorsen)
WAYLIVRA is the only therapy indicated for people with familial chylomicronemia syndrome (FCS). Akcea is working to confirm a path forward for WAYLIVRA in the U.S. and Canada.
WAYLIVRA, a product of Ionis’ proprietary antisense technology, is designed to reduce the production of ApoC-III, a protein that regulates plasma triglycerides and may also affect other metabolic parameters.
The European Commission’s marketing authorization of WAYLIVRA is based on results from the Phase 3 APPROACH study and the ongoing APPROACH Open Label Extension (OLE) study and is supported by results from the Phase 3 COMPASS study. Results from the Phase 3 APPROACH trial, the largest study ever conducted in patients with FCS, show that in comparison to placebo, treatment with WAYLIVRA reduced triglycerides 77% (-94% when compared to placebo). All patients in the trial maintained a low-fat diet.
WAYLIVRA is associated with risk of thrombocytopenia. Enhanced monitoring is required to support early detection and management of thrombocytopenia. The most frequently observed adverse reactions (more than 10%) during treatment with WAYLIVRA were events associated with injection site reactions and reduction in platelet levels/thrombocytopenia.
The WAYLIVRA Early Access Program (EAP) has been initiated in Europe, the U.S. and Canada and is currently enrolling eligible patients. Click here for more information on the WAYLIVRA EAP. For more information on WAYLIVRA, please visit www.WAYLIVRA.eu.
WAYLIVRA is also currently in Phase 3 clinical development for the treatment of patients with familial partial lipodystrophy, or FPL. Akcea anticipates reporting top-line data from this study in mid-2019.
About FCSFCS is an ultra-rare disease caused by impaired function of the enzyme lipoprotein lipase (LPL) and characterized by severe hypertriglyceridemia (>880mg/dL or 10mmol/L) and a risk of unpredictable and potentially fatal acute pancreatitis. Because of limited LPL function, people with FCS cannot breakdown chylomicrons, lipoprotein particles that are 90% triglycerides. In addition to pancreatitis, FCS patients are at risk of chronic complications due to permanent organ damage, including chronic pancreatitis and pancreatogenic diabetes. They can experience daily symptoms including abdominal pain, generalized fatigue and impaired cognitions that affect their ability to work. People with FCS also report major emotional and psychosocial effects including anxiety, social withdrawal, depression and brain fog. Additional information on FCS is available at www.fcsfocus.com, through the LPLD Alliance at www.lpldalliance.org and through The FCS Foundation at http://www.livingwithfcs.org. For a full list of organizations supporting the FCS community worldwide, please click here.
ABOUT IONIS PHARMACEUTICALS, INC. As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can treat diseases where no other therapeutic approaches have proven effective. Our drug discovery platform has served as a springboard for actionable promise and realized hope for patients with unmet needs. We created the first and only approved treatment for children and adults with spinal muscular atrophy as well as the world’s first RNA-targeted therapeutic approved for the treatment of polyneuropathy in adults with hereditary transthyretin amyloidosis. Our sights are set on all the patients we have yet to reach with a pipeline of more than 40 novel medicines designed to treat a broad range of diseases including cardiovascular diseases, neurological diseases, infectious diseases, pulmonary diseases and cancer.
To learn more about Ionis follow us on twitter @ionispharma or visit www.ionispharma.com.
ABOUT AKCEA THERAPEUTICS, INC. Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc., is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious and rare diseases. Akcea is commercializing TEGSEDITM (inotersen) and advancing a mature pipeline of novel drugs, including WAYLIVRA® (volanesorsen), AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, with the potential to treat multiple diseases. All six drugs were discovered by and are being co-developed with Ionis, a leader in antisense therapeutics, and are based on Ionis’ proprietary antisense technology. TEGSEDI is approved in the U.S., E.U. and Canada. WAYLIVRA is approved in the E.U. and is currently in Phase 3 clinical development for the treatment of people with familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally. Akcea is a global company headquartered in Boston, Massachusetts. Additional information about Akcea is available at www.akceatx.com and you can follow us on twitter at @akceatx.
AKCEA’S AND IONIS’ FORWARD-LOOKING STATEMENTThis press release includes forward-looking statements regarding the business of Akcea Therapeutics, Inc and Ionis Pharmaceuticals, Inc. and the therapeutic and commercial potential of WAYLIVRA® (volanesorsen) and other products in development. Any statement describing Ionis’ or Akcea’s goals, expectations, financial or other projections, intentions or beliefs, including the commercial potential of WAYLIVRA or other of Akcea’s or Ionis’ drugs in development is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Akcea’s and Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea’s and Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea and Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea’s and Ionis’ programs are described in additional detail in Akcea’s and Ionis’ quarterly reports on Form 10-Q and annual reports on Form 10-K, which are on file with the SEC. Copies of these and other documents are available from each company.
In this press release, unless the context requires otherwise, “Ionis”, “Akcea,” “Company,” “Companies” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and/or Akcea Therapeutics.
Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics®, TEGSEDITM and WAYLIVRA® are trademarks of Akcea Therapeutics, Inc.
Akcea Investor Contact: Kathleen Gallagher Vice President, Corporate Communications and Investor Relations (617)-207-8509 [email protected]
Akcea Media Contact: Bill Berry Berry & Company T: 212 253-8881 [email protected]
Lynn Granito Berry & Company T: 212 253-8881 [email protected]
Ionis Investor Contact: D. Wade Walke, Ph.D. Vice President, Investor Relations 760-603-2741 [email protected]
Ionis Media Contact: Roslyn Patterson Vice President, Corporate Communications 760-603-2681 [email protected]

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To learn more about meat, here are our top videos about meat:

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Yesterday was a 5-star day: I maintained the integrity of my calorie budget, I remained refined sugar-free, I met my daily water goal, I completed a great 5K walk in the park, and I stayed well connected with exceptional support.
I took to the walking trail last night determined to make it a 5K walk. I completed the 5K and it felt great. I was trying to rationalize stopping at 2.7 miles, but I just couldn't find a good enough reason to stop short of my goal. About that time, a really good song came on and it helped propel me around the trail one more time.
The trail has changed quite a lot since I started on the night of September 15th, 2008. None of the original pavement exists, all replaced with new, wider concrete pathways. I still have a chunk of the old walking trail. I plan on displaying it in my living room at some point. That trail is so symbolic for me. I worked through so much out there. It's a very special place for me.
It's been all about grandkids the past two days. I just got back from a family get-together where two of my four grandkids hunted Easter Eggs. Following the hunt, we all made our way over to the ball fields to cheer Noah on at his T-ball game. There was a mixup about the start time because we were all convinced the game started at 6pm. Instead, it was a 7:15pm start. I'm home much later than I planned but it was certainly worth every minute.
One of my earliest positive visualizations was being able to actively be a part of my future grandchildren's lives. If I had stayed the same at 500 pounds, who's to say I'd even be alive right now. I'm grateful for the opportunities I have today. The opportunity to live and experience joy.
This big "before" picture was after I'd lost a hundred pounds back in 2004. We were on a tour of Royals stadium. I remember that day being very difficult to maneuver, even at 400 pounds. Places that required lots of walking and stair climbing were typically places I tried to avoid back in those days.
I used this particular before picture just so I could puntastically say: If you're ready to get off the bench and back into the game of life, join my small and exclusive private support group! Okay, I know puntastically isn't really a word. But I like it. Anyway-- one space remains for the session starting this Wednesday. If you're interested in details, check out yesterday's blog post. You can certainly email your questions directly to me: [email protected]
5k walk in the park✅Done. Felt great! It was a walk in the park, literally. #intentionalmovement #endorphinrelease pic.twitter.com/0Uizgw9hM3— Sean Anderson (@SeanAAnderson) April 22, 2019
If you're interested in connecting via social media:
I accept friend requests on MyFitnessPal. My daily food logging diary is set to public.
MFP Username: SeanAAnderson
My Twitter: SeanAAnderson
Facebook: www.facebook.com/seananderson505
Instagram: SeanAAnderson
Also--I'd love you to subscribe to my podcast Transformation Planet! You can find it in Apple Podcasts, in the Google Play store for Android, and listed wherever you find your favorite podcasts! If you haven't listened before, you'll find 20 episodes waiting for you!
Questions or comments? Send an email! [email protected]
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Alcohol intake used to be on the list of reasons explaining why the prevalence of obesity is increasing in the country. The syrupy drink with the umbrella on top, the drink containing heavy cream mixed into the sugared chocolate liqueur, or the weekend six pack of beer were pointed out as obvious sources of excessive calorie intake. Dieters were told not to overlook the calories in wine (two 5 ounce glasses contain approximately 240 calories), and stick to tonic water rather than a gin and tonic for the second drink during the wedding reception. All good advice, but it seems some of it may no longer be accurate. Might alcohol intake be permissible on a diet? And even more provocative: Might drinking somehow prevent weight gain?
There are countless studies looking at whether alcohol consumption causes obesity, and the results are about as mixed as a cocktail. An excellent review by Traversy and Chaput indicates little evidence that frequent light-to-moderate alcohol intake is associated with obesity. A review by Suter confirms this as well.
Moreover, light-to moderate drinking may actually be associated with a smaller chance of becoming overweight or obese, when compared to no drinking. Compelling evidence for this comes from a study that followed 19,220 US women for almost 13 years. The women, aged 39 years+ at the start of the study, were healthy and of normal weight. Their average alcohol intake at baseline ranged from, ‘Never Drink’ to ‘Drink more than 6 alcoholic beverages a week.' What they drank was also recorded, and the alcohol content calculated in grams. Four ounces of red or white wine has 10.8 g of alcohol, 1.5 oz. of liquor, i.e. gin or vodka, contains 15.1 grams of alcohol, and 12 ounces of beer, 13.2 g.
Only 3% of the women drank as much as 2-3 drinks a day. In other words, this was not a ‘heavy drinking’ population. When the women’s weights were reported at the end of the study, the group with the smallest number of overweight or obese individuals was the one made up of individuals who consumed light-to-moderate amounts of alcohol.
These results, and those from other similar studies, make a compelling argument for allowing light-to-moderate alcohol intake on a weight maintenance regimen, and little reason to deny dieters 4 to 5 ounces of wine or liquor, once or perhaps twice, weekly. Heavy drinkers do not get a pass on this however, because many other studies have shown that they are at significant risk of becoming obese. Several studies such as the one that recorded the energy (calorie) intake from alcohol among men whose drinking ranged from none-to-heavy found that those in the group with the highest calorie intake from alcohol had a 70% greater risk of becoming obese compared to those who drank little or nothing.
As they say, ‘There is no free lunch!’ or in this case, ‘No free drink.’ Alcohol consumption still has its nutritional perils. Having a drink prior to a meal may loosen control over subsequent food choice, so that foods normally avoided because of their high calorie content will be eaten. Drinking during a cocktail reception is just as hazardous. Nuts, barbecued chicken wings, and high fat dips may be consumed at a bar or reception without really being perceived as being calories ingested by the wine, beer, or hard liquor drinker. Moreover, alcohol has calories; 7 calories per gram. Fat as a comparison contains 9 calories per gram. Alcohol is metabolized differently than food, which some say may account for some of its calories being wasted, rather than used or stored as energy. However, alcohol can be converted to fatty acids and eventually stored as fat.
Weight losers/Maintainers may decrease their food intake to compensate for alcohol calories. Like sugar, alcohol has no nutritional value other than calories, so eating less may mean not obtaining the nutrients the body demands to remain healthy. A container of fat free yogurt at 100 calories containing essential calcium, vitamin D, and protein may be excluded in order to save calories for a glass of wine or can of beer. Indeed, an extreme example of not eating in order to drink, sometimes excessively, has been given a name; drunkorexia. It has been written about in the media as a worrisome practice on college campuses, but is probably not restricted to that age group. Predominantly women who engage in heavy drinking jettison eating, in favor of alcohol consumption. Their dieting mantra might be, ’Many drinks a day will keep the pounds away…if you don’t eat.’
To summarize, alcohol is not one of the four basic food groups, and its consumption in place of foods from these food groups that must be eaten to sustain heath is nutritional idiocy. On the other hand, research has shown that small amounts of alcohol can be consumed for its positive impact on mood, without risking weight gain or indeed weight loss. The key is moderation and wise food intake along with that drink.

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In the middle of November, Beyond Meat — a company that makes plant-based meat substitutes — announced it was going public on the Nasdaq stock exchange to better raise money for “the future of protein.” (“The future of protein” is also its tagline; “the future” is made primarily of peas.) Beyond Meat’s best-known product to date is the vegetable-based Beyond Burger, which is like a regular meat burger but Beyond.
Unlike its competitors — Gardein, which sells a menagerie of non-meat meats; Tofurky, famous for its bulbous imitation poultry; Field Roast, which does fake meat in wholesome packaging; and Morningstar Farms, maker of “America’s #1 Veggie Burger” — Beyond Meat is aiming not just to capture the hearts and minds of vegetarians but to win over people who eat actual hamburgers. It wants to be sold “where meat-loving consumers are accustomed to shopping for center-of-plate proteins,” according to the prospectus filed with the Securities and Exchange Commission. You can find it in “approximately 11,000” grocery stores across the US, which is more than a quarter of them.
The ubiquity of the Beyond Burger is part of one of 2018’s best movements: the mass proliferation of vegan junk food. Democracy may be crumbling around us, but it was a banner year for delicious processed food that just so happens to be meat- and dairy-free. And not just any vegan junk food but mainstream vegan junk food, products engineered not to satisfy vegan-identified vegans, but to tempt regular omnivores who are interested in novelty, or climate change.
It goes beyond Beyond, of course. Daiya, a leading purveyor of fake cheese, debuted non-cheese cheese burritos this year, as well as a “meat lovers” pizza without meat. Vegan fast-food chains — Instagram darling By Chloe, “veggie-positive” Veggie Grill — kept expanding, while regular fast-food chains like McDonald’s experimented with vegan options. It is enough to have unleashed an existential and legal crisis over labeling: What is “milk”? What is “meat?” The dairy lobby is worried. Big Beef is making preparations.
None of this is even to mention the Impossible Burger, the true icon of Our Year of Vegan Junk. “Few people may have expected a wheat-potato-coconut-fat patty to become perhaps the country’s most famous burger,” wrote New York magazine’s Grub Street, “but the Impossible Burger is now an impossibly big deal.” When the “bleeding” non-meat burger was introduced in 2016, you could only get it at the restaurants of an elite quartet of chefs, including the famously carnivorous David Chang.
Now, the patty, which gets its bloody look and taste from heme (the compound that gives meat its essential meatness), is at more than 1,000 restaurants, including White Castle, a chain best known for a movie about college students who get stoned. It is an unlikely pairing!
“As the larger fast-food industry pays lip service to healthier offerings and builds cushier environs,” Eater explains, “White Castle remains a cultish, ultra-affordable, bare-bones outlier.” The move does not represent an overhaul of White Castle’s strategy — cheap, a little gross — but rather a gleeful celebration that non-meat meat can also be cheap and a little gross, which is a sort of progress. A slider at White Castle costs $1.99, double the original meat burger but still less than almost anything else edible.
This is great. Not because the food is virtuous — the food is White Castle — but because it indicates a shift in how meat-and-potatoes Americans think about vegan food. It is not just for hippies; it is also for people who frequent drive-thru windows. I know this firsthand, thanks to a drive-thru window in New Jersey. I ate my vegan slider in the parking lot, like a patriot.
Can vegans eat this food? I mean, yes, obviously. Vegans are very good at sussing out sources of relevant nutrients, much like squirrels. But despite the apparent rise of “plant-based” eating, the number of vegans and vegetarians in America is small and hasn’t grown much in the past 20 years. According to a 2017 Gallup poll, the Washington Post reported, 5 percent of Americans identify as vegetarian, while 3 percent said they were vegan. The last time the poll was taken, in 2012, the percentages were 6 and 2. Either way, the total is the same: 8 percent of Americans identify as some category of veg-something.
So the total number of veg-somethings hasn’t changed, but veg-something food options have ballooned, not only in number but in quality. This would make little sense if the target customer for vegan food was vegan. But the target customer isn’t veg-anything. “The average customer trying out an Impossible or Beyond burger,” mused Time, is not a lifelong vegetarian but a meat eater “looking for food that is better for their bodies and for the planet.”
In fact, plenty of actual vegans don’t even like all this real-seeming fake meat! “I’ve seen vegans eat it and find it to be something that they don’t want to eat again,” Chang told the Ringer about the Impossible Burger. “I had a vegetarian actually turn it away, because it reminded them so much of meat, they sent it back,” a Kansas City server recalled to NPR.
If you’re truly weirded out by meat, it’s possible you don’t actually want an uncannily accurate bleeding imitation. This doesn’t matter. The thing about vegans is that they are already vegan; they don’t need to be sold on the idea. It’s everyone else that does.
Could you say that this food — backed by venture capitalists and sold by major corporations — in fact continues to uphold a very broken system? Yes! This food is not radical. It is not politically disruptive. A fast-food chain can serve vegan burgers and still exploit its workers.
As the Guardian points out, given the amount of money behind these projects — funneling in from Silicon Valley investors, hedge funds, “hipster entrepreneurs,” Leonardo DiCaprio — “it’s easy to see why some vegans feel that the movement’s traditional association with anti-capitalism is a position rapidly disappearing in a fog of marketing hype.” This is fun! quick! easy! veganism that photographs well on Instagram. It is the least principled kind of veganism there is. But also, it might work.
Despite a constant stream of evidence that the current American diet is environmentally unsustainable, vegans, on the whole, have been remarkably bad at recruitment. The problem is twofold. People really like eating meat. Also, people really don’t like vegans.
As Abigail Higgins laid out earlier this year at Vox, there are a number of reasons for vegans’ relative unpopularity (a 2017 analysis suggested that just “labeling a product as ‘vegan’ causes its sales to drop by 70%”). One is that vegans make people feel bad. “People tend to interpret someone’s choice not to eat meat as condemnation of their own choices, which can make them pretty defensive,” Higgins explained. And this defensiveness isn’t totally misplaced. It’s true that a lot of vegans believe, for any number of reasons, they are doing the right thing, which indeed indicates that they believe a) there is a “right” thing, and b) you’re not doing it.
Meat is also pretty ingrained into our lives, and in general, people do not like their lives disrupted. Plus, vegans tend to be annoying about their veganness. (Not all vegans, etc; I, for one, am a casually vegan delight.)
That is what makes the rise of mass-market vegan junk food so powerful. It defies stereotype: Vegan food in America is supposed to be joyless and unfulfilling, seasoned only with the fermented tang of the moral high ground. And to be vegan is not simply a lifestyle choice but a statement of identity: It’s to declare that you have enough time and energy and resources to devote to the care and keeping of your electively restrictive diet. It is also to announce, however passively, that you believe so strongly in this cause — for ecological or ethical or animal rights-related reasons — that you are willing to change how you eat, likely every day, maybe forever.
But vegan junk food does not demand devotion to any cause. Unlike rice and greens and beans — also very tasty! — you should definitely not eat vegan junk food every day forever. Many articles about vegan junk food will point out, alarmed, that this food actually isn’t that healthy. It’s heavily processed! It’s high in fat! Sometimes, it’s even higher in fat than the original meat version! A study from Harvard’s Department of Nutrition concluded that “not all plant foods are necessarily beneficial for health,” the New York Times gravely reported.
And it’s true. Vegan hamburgers and chick’n nuggets, like regular hamburgers and chicken nuggets without apostrophes, should probably not be a primary staple of anyone’s diet. That is the point of junk food: It is for sometimes. “We’re avoiding being healthy,” one (high-end) restaurateur told Grub Street of his new vegan venture. “We’re trying to go for tasty food that’s satiating.”
This is the promise of vegan junk food. It’s not especially virtuous, on account of being generally processed, and this lack of virtue makes it fun. Junk food isn’t the only fun vegan food — lots of vegan food is fun, I think — but for non-believers, it is a shortcut. Accessible and nonjudgmental, non-meat junk may be the most efficient way to untether vegan food from its moralistic baggage.
Vegan junk food is not elitist or unfamiliar or salad-like. It’s an option, a novelty, an experiment. At best, it is an introduction, evidence that vegan food is not only for militants and health nuts and hippies eating lentil loaf. At worst, it’s one less meal that does not require a cow.

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Typical meals for Hayden do not include trending "fat bombs" or "no egg breakfast bakes." Most of the more than nine million ketogenic diet recipes available on the Internet are for weight loss keto and often involve more grams of carbohydrate and protein than Hayden is allowed. So what does Hayden eat on a given day? "Cheese Soup," which is made with heavy whipping cream, butter and shredded cheddar cheese, is one example. To fulfill his carb option with his soup, Hayden will typically eat 5 blueberries or one Cheetos cheese curl puff. Other examples include scrambled eggs with mayonnaise plus strawberries served with heavy whipping cream to drink on the side or "mac and cheese", which is less than a small handful of plain cooked ramen noodles topped with a mixture of heavy whipping cream, butter and cheddar cheese. With such little variety in Hayden's diet, Erika's staple ingredients include mayonnaise, butter, vegetable oil, heavy whipping cream, fish oil and sour cream.

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Duration: 00:52 7/26/2018
Do you tell the truth about your sexual life? A new study found that men report far more lifetime opposite-sex sexual partners than women, but their numbers may be overstated. Buzz 60's Chandra Lanier has the story.

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Yesterday was a 4-star day: I maintained the integrity of my calorie budget, I remained refined sugar-free, I met my daily water goal, and I stayed well connected with exceptional support.
The past couple of days have been packed tight schedule-wise. When days come like this it requires me to plan better and make sure I'm at least having a good, solid morning foundation routine. Then, I hold on and go!
Morning show this morning, location broadcast midday, a haircut, vehicle service, and I'm about to hit the road for Oklahoma City's Skirvin Hotel, the sight of tonight's Oklahoma Association of Broadcasters Awards Banquet. The meal is a mystery to me, but I'll employ the same strategy I used last year: I'll survey the selections and ask for what I need. It worked perfectly last year, but that was a different venue. We'll see. If the meal doesn't work for my food plan, I'll have a backup plan in my bag, waiting for me after the event. It shouldn't be an issue. For me, the worst would be something covered in a sugary glaze. One thing I've learned along this road is to ask for what I need. Nine times out of ten or better, I've found people will go out of their way to accommodate the special requests. I'm worth it!
I can remember a time when I wouldn't even think to ask for what I need. I'd just accept whatever was served my way as if I didn't have a choice. I do have a choice. Events like this don't come with a menu. Everyone is served the same thing unless you have certain dietary requirements, like me--and I assure you, I won't be the only one!
I'm excited about the awards, catching up with former colleagues I never see but once a year at this event, and seeing/listening to the award-winning segments. It's a good time!
It's going to be a late night! But totally worth every minute!
Thank you for reading and your continued support,
Practice, peace, and calm,
Sean
If you're interested in connecting via social media:
I accept friend requests on MyFitnessPal. My daily food logging diary is set to public.
MFP Username: SeanAAnderson
My Twitter: SeanAAnderson
Facebook: www.facebook.com/seananderson505
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N&S: Given the new evidence, is it wrong for doctors to immediately suggest medication for type 2 diabetics or pre-diabetics without suggesting intermittent fasting?
MM: I’m surprised by how many doctors haven’t heard of this approach. I think it’s wrong if they don’t look into it, or don’t at least suggest patients investigate it. There’s a fear patients will feel offended if their weight is mentioned, but actually they generally don’t.
N&S: A couple of women have told me that, when they were obese, their GPs never brought up their weight. Both wonder whether that’s because their doctors were overweight themselves. Another woman told her doctor she’d reversed her pre-diabetes [raised blood sugars] through 5:2, and the doctor didn’t show any interest.
MM: I’m surprised [the latter GP] wasn’t curious, because if a patient transformed themselves, I’d want to know how. And do you really want advice about weight loss from someone with weight issues? But please, do tell your doctors about 5:2 – that’s how these things often spread.
N&S: Dementia is expected to affect 150 million people by 2050. It’s as yet unproven that 5:2 could help prevent it?
MM: Frankly, we’re waiting on US neuroscience professor Mark Mattson’s current study to see if 5:2 can protect and boost the brains of people who are at increased risk of developing dementia. He says interim results are encouraging. His findings are expected to be out later this year. He’d previously done animal studies that show intermittent fasting can help combat memory loss and delay dementia.
N&S: You write that 5:2 can help prevent cancer, because carrying too much fat or having high insulin levels are risk factors for cancer. What if you already have cancer?
MM: It’s early days with research on that. But Dr Valter Longo, a human-ageing expert, found that time-restricted eating seemed to have a significant impact on the risk of breast cancer recurrence. He believes fasting has the potential to delay ageing and prevent the onset of diseases such as cancer and heart disease. On his “Fasting Mimicking Diet” [FMD], people eat 800 calories a day for a fixed number of consecutive days, mainly vegetables, olive oil and nuts. A dozen clinical trials worldwide are looking at FMD’s effect on various conditions, including breast cancer in women who had already had chemo.
N&S: How might 5:2 improve your heart health?
MM: First, by helping you lose weight. Second, by improving your insulin sensitivity. And a small study showed 5:2 had a significantly bigger impact on blood pressure than losing weight by another method. Watch this space.
N&S: When asked about intermittent fasting, Dr Fredrik Karpe from the Oxford Centre for Diabetes, Endocrinology and Metabolism said it’s “very important to critically investigate health plans for interventions giving great promises”. So many experts are still sceptical about intermittent fasting.
MM: I’m very sceptical by nature. But scientists have critically investigated all this – and still are. I sometimes collaborate on a few small studies. Mainly, though, I weigh up various claims and studies. People get understandably confused about conflicting evidence so, in the book, I explain different types of studies and the most reliable ones – particularly randomised, controlled trials. Government advice actually ranks amongst the weakest evidence. And I always look at, for instance, how big the trial is, who conducted it, who funded it, etcetera. Plus, I acknowledge gaps in scientific knowledge, and very much hope others will fill those gaps.
N&S: Back to the practical stuff. You’ve included lots of tips for doing 5:2, such as talking to others about the approach, writing things down, etcetera. How important are psychological techniques to success?
MM: Do your psychological techniques really matter that much if you feel starving? The practical steps are most important. For instance, actually doing the rapid weight loss stage will help change hunger hormones and suppress your appetite. However, psychology is clearly important regarding things like doing 5:2 with others, having clear goals, practising mindfulness, managing stress, and trying to sleep well.
N&S: If it’s too hard, you say take a break?
MM: Yes. Perhaps try intermittent dieting. It seems counter-intuitive but the Australian MATADOR study’s small trial of obese men showed “two weeks on, two weeks off” was beneficial. The intermittent dieters lost – and kept off – more weight than men who dieted throughout. Why? Perhaps it counters dieting fatigue.
N&S: Plus everyone on a diet needs breaks, especially over the Christmas season! You also say that, if you find 5:2 difficult, try 2:5 where you eat 800 calories a day during the week and don’t fast on weekends. That sounds much harder than 5:2.
MM: I’m being pragmatic. I’m providing a toolkit you can dip into to suit your needs. I think being overly prescriptive is unhelpful. For instance, it doesn’t matter if you’re 50 or 100 calories over or under.
N&S: On weekdays, my friend eats 1100 calories and exercises, then on the weekend eats junk food and drinks a fair bit of alcohol. Is that bad for her?
MM: Our ancestors had long periods when they wouldn’t eat much, and occasionally gorge, but there are no particular studies on this. Is she a decent weight, sleeping okay, and are her cholesterol and blood sugars under control?
N&S: Yes, and she’s got a body like Charlize Theron’s.
MM: I wouldn’t knock her approach then!
N&S: Should people of a healthy weight do 5:2 for health benefits?
MM: The honest truth is I don’t know. There’s some evidence it can benefit slim people, but right now I’m reluctant to suggest it. I’ve just been talking to researchers about doing a study looking at healthy people on the 5:2 diet. We just need to find funding, because slim people are not any health authority’s priority.
N&S: In the book, you note that people with certain health conditions, etcetera, shouldn’t do 5:2, or should consult their doctor. And people who once had eating disorders shouldn’t do it?
MM: I say that based on caution, not on science. One small study showed that people with current or past eating disorders actually do better on intermittent fasting, but I don’t want to put anybody at risk, because as a doctor I’ve sworn to “first, do no harm”.
N&S: You do a lot. Do you overwork yourself?
MM: I write books relatively fast but, before that, I collect data, studies, people’s stories, and talk to experts. I haven’t totted up my hours, but, blimey, I probably should slow down a bit.
N&S: Has anyone asked you if you’re just in it for book sales?
MM: Regularly. Mainly online. When one person asked that online, I replied “It’s all free online”, in my articles, and there’s a website for each book. But some people prefer something they can hold and flick through. Money has never been my main motivation. I just really want people to know this stuff.
This article was first published in the February 2019 issue of North & South.
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