Categories
WEIGHT LOSS

Ellie Goulding and Caspar Jopling Married

[ad_1]

LONDON, ENGLAND - JUNE 19:  Ellie Goulding attending the Serpentine Gallery and Chanel Summer Party 2018 on June 19, 2018 in London, England.  (Photo by Mark Milan/GC Images)

Ellie Goulding is married! Goulding tied the knot with long-time partner Caspar Jopling at York Minster in front of friends and family on Saturday, Aug. 29. The pair announced their engagement back in August 2018 the old-fashioned way, via an announcement in The Times newspaper.

The guest list was a who’s who of British celebrities, with Sienna Miller and Orlando Bloom (plus fiancée Katy Perry) in attendance. Perhaps most notably, though, was the strong British royal contingent, with the presence of Princess Beatrice and Princess Eugenie along with their mother Sarah Ferguson; additionally, Jack Brooksbank, Princess Eugenie’s husband, was pictured among the groomsmen, according to Hello! magazine.

The bride arrived in a vintage Volkswagen camper van decked out with ribbon and white flowers. She stunned in a silk double crêpe Chloé gown that was designed by Natacha Ramsay-Levi. The bespoke dress, which featured a high-neck and long sleeves and took more than 640 hours to make, was hand embroidered with White Roses of York and delicately embellished with white glass beads. The groom also kept it traditional in a black morning suit with pale grey waistcoat and trousers, and a royal-blue tie.

The “Love Me Like You Do” singer has been dating Caspar, an art dealer and former Eton College student, since early 2017. Caspar has shared photos of Goulding on his Instagram, and his photography skills are nearly as adorable as his captions. Congratulations to the happy couple!



[ad_2]

Source link

Categories
NEWS

‘Locally grown’ insurance companies help fortify Washington state market

[ad_1]

Although few states have finalized their 2020 health insurance rates yet, preliminary reports suggest that increases in premiums for plans sold on the Affordable Care Act’s marketplaces will be moderate again this year.

One analysis of those early state filings, which noted some states appear poised to have lower premiums next year, found that Washington had a lower rate increase than almost half the other states.

Insurance premiums for Washington’s individual market are rising less than 1 percent on average next year, and the state’s insurance commissioner, Mike Kreidler, credits much of that moderation to homegrown insurance companies.

“We’ve had locally grown insurers that dominated the health insurance market for individuals,” Kreidler said. These insurers are tied to the local community and must succeed in Washington or in the Pacific Northwest region to stay in business. That motivates them to try harder to meet the needs of their customers, he said.

“Insurers that are local and tied to the community — not from out of state, coming in and out — they were ones that need to stay or they weren’t going to be in business,” Kreidler said.

Nearly 250,000 people who do not get coverage through their employers or the government buy health insurance in Washington’s individual market, most of them shopping on the state’s ACA exchange, the Washington Healthplanfinder.

The individual insurance market here features companies that do business only in the Pacific Northwest, such as Asuris Northwest Health and Premera Blue Cross. Both nonprofits have been selling health insurance in the region for many years. Premera and its subsidiary LifeWise Health Plan have taken about 13 percent of the total health insurance market in Washington, selling to companies and individuals, both inside and outside of the Obamacare marketplace.

“Local plans can really make a difference in stabilizing their state-based marketplace,” said Emily Curran, a research fellow at the Center on Health Insurance Reforms at the Georgetown University Health Policy Institute in Washington, D.C. They help fill in geographical market gaps and build better partnerships with local doctors and hospitals, and are more effective at reaching underserved populations.

One key to their success, she said, is their commitment to a local market. They can succeed only if they make the business work locally.

“They have an incentive to make sure the market is stable,” she said.

Premera, based in Mountlake Terrace, a Seattle suburb, has been selling insurance in Washington for more than 80 years and is now an independent licensee of the Blue Cross Blue Shield Association. It sells plans in 38 of the state’s 39 counties and also operates in Alaska.

Asuris has been in the Washington market since 1933 and became part of Portland, Ore.-based Cambia in 1994. Asuris, which is too small to make the top 10 list of insurers in the state, sells health insurance outside the ACA marketplace. Its products are available in eastern Washington and Oregon as well as northern Idaho.

But the two largest companies in Washington’s health insurance market are based elsewhere: Kaiser Foundation Health Plan has seized 19 percent of the market and UnitedHealth Group controls 14 percent. Washington’s Healthplanfinder has shrunk slightly since 2014, from eight companies to six in 2019, but two new outside companies plan to join the market in 2020. (Kaiser Health News has no ties to Kaiser Permanente or the Kaiser Foundation Health Plan.)

Homegrown insurance companies aren’t as prominent in other states, where national companies dominate most markets. But Curran said New York is another example of a state with a base of local insurers.

Companies with a bigger footprint can afford more customer churn in their business. The smaller guys need to hang on to its customers, so they offer a wide variety of insurance options, in gold, silver and bronze tiers, both inside and outside of the state marketplace.

But buying from a local plan sometimes has disadvantages. Some companies’ plans limit consumers’ ability to get full health coverage in other parts of the nation. While local companies are more likely to have agents and brokers who know their customers and their plan offerings, they also have smaller teams than the big national companies and may not be available on weekends and at night, so they cannot respond as quickly to customers’ requests.

While Asuris has considered expanding — to the Seattle market, for example — Brady Cass, its president, said that just doesn’t make business sense. “Health insurance is personal and it’s very local,” he said, adding that companies that find their niche, as Asuris has, can more easily weather marketplace storms.

Asuris also markets itself to local companies. Cass, who is a Washington native and has worked for Asuris for 14 years, mentioned examples such as a concierge program Asuris started for both employers and individuals that is designed to help immigrants from Latin America. His company also sent crisis counselors to a workplace where an employee had died on the job.

Barry Baker, CEO of Baker Construction & Development in Spokane, Wash., said Asuris helped his company find economical options for both the company and its employees.

Baker also likes that Cass is involved in his community; they have served on several nonprofit boards together. “He’s super community-minded,” Baker said. They share business values, making a profit but also putting their profit back to work right where it was earned, he said.

Said Cass: “We’ve kept our feet squarely in the market that we have built.”

Photo: turk_stock_photographer, Getty Images

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

[ad_2]

Source link

Categories
NEWS

USPTO agrees to Amgen’s petition to review Alexion’s patents on rare disease drug

[ad_1]

The U.S. Patent and Trademark Office’s has agreed to review patents covering a drug used to treat rare blood disorders.

On Friday, the USPTO’s Patent Trial and Appeal Board announced in documents on its website that it would institute an inter partes review regarding Boston-based Alexion Pharmaceuticals’ drug Soliris (eculizumab), used to treat the disease paroxysmal nocturnal hemoglobinuria, or PNH, after Thousand Oaks, California-based Amgen filed a petition for the IPR. The biotech company has been developing a biosimilar version of Soliris called ABP 959, which is currently in a Phase III study enrolling up to 40 PNH patients.

Shares of Alexion fell more than 11 percent on the Nasdaq Friday following the news. Soliris had sales of $3.6 billion last year, and in addition to PNH is also approved for atypical hemolytic uremic syndrome, or aHUS.

IPR is a legal proceeding that was created under the America Invents Act in 2012 and is a way to challenge the validity of a patent before the USPTO. In a statement emailed by a spokesperson, Alexion noted that the IPR process takes about 12 months, and a final outcome is expected about 18-24 months from now. The company said it was “disappointed” that the USPTO instituted IPR proceedings to review three of the patients covering Soliris in PNH that cover composition of matter, formulation and methods of use in the disease.

“However, the institution of these proceedings does not predict the outcome of the case. We strongly believe in the strength of our patents and will vigorously defend them in the course of the IPR proceeding,” the statement read.

Amgen did not immediately respond to a request for comment.

Ahead of Soliris’ eventual patent expiration, Alexion has also launched a successor drug, Ultomiris (ravulizumab-cwvz), which belongs to the same class but is longer-acting than Soliris. In its statement, the company said data demonstrate a “strong preference” among PNH patients for Ultomiris, based on its being dosed every eight weeks, compared with every two weeks for Soliris. Ultomiris won approval for PNH last year and is in development for aHUS and other diseases as well.

Photo: Chris Ryan, Getty Images

[ad_2]

Source link

Categories
NEWS

Federal judge rules in favor of Sanofi, Regeneron in patent suit over cholesterol drugs

[ad_1]

A federal judge ruled against biotech giant Amgen in a patent-infringement lawsuit it had filed against Regeneron Pharmaceuticals and Sanofi over the companies’ competing cholesterol drugs.

On Wednesday, Judge Richard Andrews of the U.S. District Court for the District of Delaware ruled against the Thousand Oaks, California-based company in its suit, which it originally filed in October 2014, against Paris-based Sanofi and Tarrytown, New York-based Regeneron. Amgen alleged that the latter companies’ drug, Praluent (alirocumab), infringed on patents protecting its product, Repatha (evolucumab). The ruling overturns a decision by a federal judge in Amgen’s favor two years ago and means Praluent can stay on the market.

Amgen did not immediately respond to a request for comment.

“Today’s decision by the U.S. District Court for the District of Delaware validates our position that Amgen’s patents are overly broad and invalid,” Regeron general counsel Joseph LaRosa said in a statement. “Praluent was developed using Regeneron’s proprietary science and technology, and the judge has confirmed our position by issuing this ruling.”

Earlier this year, in February, a jury had found in favor of Regeneron and Sanofi, that two other patent claims Amgen had asserted were also invalid. As such, it means that the two companies have invalidated all five of the patent claims Amgen had asserted.

Both drugs have Food and Drug Administration approval for use together with cholesterol-lowering medications in patients with homozygous hypercholesterolemia who require addition lowering of LDL cholesterol. The drugs belong to a class known as PCSK9 inhibitors, which target a protein that reduces the liver’s ability to remove LDL cholesterol from the blood. Repatha had won approval in August 2014, and Praluent won approval the next year.

Praluent had global sales of $306.8 million in 2018, according to Regeneron. Meanwhile, Repatha’s global sales were $550 million during the same period. Both companies had previously moved to lower the prices of their respective products. In March of last year, Regneron and Sanofi lowered the list price of Praluent to $5,850 per year, a 60 percent reduction from its original price. And in October, Amgen said it would do the same for Repatha, also lowering the price by 60 percent, to $5,850 annually.

Photo: Getty Images

[ad_2]

Source link

Categories
NEWS

Realistic expectations and exaggerated drawbacks of healthcare apps

[ad_1]

hand touching visual screen

Smartphone users now think of their device not just as a means of communication, but a method of staying healthy. According to ITProPortal, the wellness mobile application market grew by 61 percent in 2018 and, thanks to these apps, users can lose weight, read their blood pressure, and perform other health tasks in a fast and flexible manner.

It’s no surprise, then, that insurance and health services providers like Cigna, CVS Health, and United HealthCare, have rolled out their own mobile apps. Users may be able to make appointments, order prescriptions, and access medical records, saving them unnecessary trips to the pharmacy or faraway clinics.

While some can focus on the convenience of these apps, others may point to their supposed drawbacks, citing prophecies about the inevitable harms of mass data collection.

Yes, there are inherent risks when gathering and storing data from health apps, just as there are potential threats that have risen from previous mass collections of information, both within and beyond the healthcare system. But most of these negative predictions regarding data mining aren’t that terrifying, nor entirely realistic.

Here’s what users can reasonably expect as mobile healthcare apps grow and evolve.

Data will be collected from the moment a user signs up for the app
In a hypothetical scenario, a smartphone owner downloads their health insurance provider’s mobile app and uses it to order a prescription refill. The user might believe that this is the first moment that the provider will mine the app for their health data, which could include the prescription itself, the credit card used to order it, or the address where it will be delivered.

But before that order is placed and completed, the user’s health info was collected the moment they signed up for the app itself. All the data that the health insurance provider has about the user is now fully integrated with whatever other tasks they complete or info they may input in the app. Even if the person never touches the app again, their non-usage is still worthwhile data for the insurer to collect.

This integration may sound eerie and ominous, but it is not a drawback to users. More faults arise in healthcare due to information being out-of-sync than it being overly holistic. At the end of the day, more integration only leads to better health outcomes.

Data will likely not be compromised or fall into the wrong hands
This isn’t to suggest that data breaches aren’t real or that the effects of one are not debilitating- but mass data breaches happen with far less frequency than one might believe.

For users of mobile healthcare apps, the possibility exists that hackers could target the data collected through these applications, leading to negative outcomes such as individuals having their identities or health records compromised. These apps, as well as the data that is collected itself, are still carefully safeguarded through a robust cybersecurity system, consisting of multiple layers of protections and protocols to keep that data safe.

One could argue that those digital protective measures are less for the users and more for the health insurance companies who also benefit from the data. Regardless of motive or whoever reaps the most value from the information, one thing is certain: the attempt is to keep the data as safe as possible.

Apps will change and evolve, and some will even die out
The emergence and rising popularity of health and wellness apps has generated convenience for users and sparked competitiveness between providers. It is entirely feasible that the allure or convenience of one mobile app may be the reason an individual switches from one insurance provider to another.

Competition between businesses in a given industry typically results in two simple outcomes: some products become better, and others do not. Within healthcare, we’ll see some of these apps unveil sleeker designs, stronger user functionality, and an increased volume and reach of services. Other apps will fall behind and become outdated, some even living as an afterthought where insurance providers no longer actively recommend the app, nor are users entirely aware of its existence.

Apps won’t be the factor that causes insurance providers to close up shop. There will not be a headline about Cigna or Kaiser Permanente going out of business because the appointment scheduling function in their mobile apps was not user-friendly enough- but apps will remain a competitive arena where providers can gain a valuable foothold.

Users will save money on healthcare
Apps can display coupons for certain medications, enabling individuals to save money without much effort. Apps can also notify users if there are more affordable methods or alternatives to health services in their area using push notifications that immediately notify the user. If a person is researching potential locations to undergo an MRI, their app might help reveal a location where the service may be offered for hundreds of dollars less from a reputed and credible provider that might be close-by but more expensive.

This isn’t to suggest that there aren’t currently faults within these mobile healthcare apps, or that apps can serve as a cure-all solution to the financial complexities of modern healthcare in the United States. As application functionalities and user bases evolve throughout the future, what remains certain, plain and simple, is that these apps will continue to help people save money on healthcare and health services.

Photo: shylendrahoode, Getty Images

[ad_2]

Source link

Categories
FITNESS

Jeera Water: Benefits and Side Effects

[ad_1]

Cumin, or jeera, is a millennium old spice that leaves an unmistakable, unique taste in your mouth. A sprinkle or two adds a flavour worthy of a kick and a punch into any dish, leaving its unique combination of aromatic tang and punchy heat inside.

Jeera has a surprisingly revitalising rusty taste that goes right through your body. In mainstream science, jeera is known to contain thymol, a chemical which stimulates the pancreas to produce enzymes and bile. This property improves overall digestion of carbs and fats within the body.

To top it off, just a whiff of jeera contains cuminaldehyde. This chemical, when just sniffed, rouses the digestive enzymes in your body and triggers your salivation impulse. Just sniffing jeera prepares your body and soul for a satisfying round of delicious food.

Table of Contents

Benefits of jeera water

Jeera is an intensely studied ingredient among researchers. It has a laundry list of proven health benefits to offer.

1. Jeera is fantastic for digestion

One of the most well-known jeera water uses. The powerful anti-gas chemicals within protect the body against irritable bowel disease and solves flatulence, belching and burps in a flash. It should be first on the list of everyone looking for a simple, quick remedy for their stomach woes.jeera water improves digestion

2. Jeera water is anti-inflammatory

The thymoquinone contained within the jeera is protective of the liver. This single chemical is so powerful it has researchers rushing to successfully extract the compound within and market it via capsules to improve digestion.

Jeera water has the compound in a safe, simple, easy to prepare manner that is all-natural and features no mysterious or unknown side effects.

3. Jeera water is legitimately anti-cancer

Jeera is medically proven to prevent free radicals from causing damage with its potent scavenging abilities. It enhances the liver’s natural detoxification pathways and aids in overall detoxification and rejuvenation. Health begins in the gut, and jeera contains compounds that promote liver health and stimulate digestive enzymes. It helps your body acquire more nutrition from food so it can work naturally to detox and heal you better.

4. Jeera water is considered an aphrodisiac

A popular folk remedy, jeera water taken with a pinch of black pepper and honey is an aphrodisiac tonic that comes with a nice, tangy kick to your taste-buds.

5. Jeera water reduces obesity

In an actual study conducted with 78 overweight participants given jeera 3 times a day for 2 months, a significant reduction in fat was noticed, along with improved insulin sensitivity and reduced stomach size.

6. Jeera improves insulin sensitivity

With constant blood sugar spikes, your blood sugar skyrockets and nosedives constantly and tires out your insulin-producing pancreas. Jeera makes your body more sensitive to insulin and reduces your blood sugar levels in the long run. Care must be taken to not ignore a good diet and proper physical activity in addition to consuming jeera water.

7. Jeera is a great hydrator

Pop some honey and freshly squeezed lemon along with a pinch of salt into your jeera water to keep your cells hydrated and fresh. Providing water and electrolytes for your body keeps them working at peak condition, and a jeera drink is a great way to accomplish that. Taking jeera water in the mornings before your workout can prevent nausea and dizziness you experience if you have a habit of skipping breakfast.

Jeera water is a phenomenally safe method of improving general wellness. However, there are some side effects we will address later on.

Jeera water for weight loss

Obesity is a serious condition the world over that causes a chain reaction of health issues and hurts the mental health of those with the condition. Increased visceral fat, high body mass indexes and insulin resistance are some of the major causes of serious metabolic disorders.

Jeera water improves your body mass index and insulin sensitivity with consistent, moderate doses outside the lab, and is medically proven to do so inside the lab as well.weight loss

1. Jeera water has almost no calories

Just a teaspoon has 7 calories. Those 7 calories are more densely packed with nutrition than several other foods. Exercising on an empty stomach is a strain on many stomachs, but sipping jeera water before going on a morning exercise routine takes care of the potential acidity issues and keeps you hydrated and calm for a good workout.

2. Jeera water with apple cider vinegar

Apple cider vinegar has compounds that prevent fat deposition when consumed and is purported to improve metabolic efficiency, allowing stable weight loss while maintaining satiety.

Adding this to your jeera water compounds the benefits with the probiotic bacteria present in the vinegar and improves your gut microbiome.

Jeera water during pregnancy

Jeera is a legendary herbal remedy the world over for pregnant women suffering from morning sickness. It is touted to reduce the pain, bloating, constipation, flatulence, insomnia during pregnancies and might even facilitate easier childbirth.jeera water for pregnancy

1. Jeera water reduces heartburn

GERD is a frequent complaint of pregnant women, as the increased pressure in the abdominals results in acid reflux and indigestion from carrying the baby. The carminative, or gas-relieving properties of jeera water offer serious relief in a simple, quick manner that can be frustrating during an otherwise difficult pregnancy.

2. Jeera water stabilises blood pressure

The stress of childbirth and carrying a child can spike blood pressure. The high magnesium and potassium in jeera water provide valuable electrolytes that let your heart do its work with ease.

How to make jeera water

Wondering how you’d like to enjoy a glass of jeera right now? Does seeing all the benefits make you long for the refreshing taste of jeera water?

The best advantage of it is the ease with which you can make a glass. Let me show you a quick, simple technique of enjoying a glass of jeera water in minutes.how to make jeera water

Ingredients

  • Gather a heaped spoonful or two of jeera
  • Gather 2 cups of water in a saucepan

Instructions

  1. To prepare the jeera water, first, begin heating the water in a pan and toss a spoon or two of jeera into it.
  2. Wait a while until the water begins to boil and allow the jeera to steep into it for an hour or so to ensure the jeera is properly infused into the water.
  3. Switch off the flame and strain the water. Sip your jeera water at leisure and enjoy every sip.

That’s all for now. Enjoy the taste of fresh, revitalising jeera water in your hands. For the best results, enjoy it on an empty stomach in the mornings, and drinking it at night keeps the acid reflux away.

For an even more delicious drink, add a pinch of cinnamon, ginger, and honey to your jeera water. You seriously won’t regret it.

Jeera water side effects

Consumed wrongly, with the wrong amount of jeera, does have its side effects. The dose makes the poison, so make sure to stay away from excessive jeera no matter how tempted you get to add more and more. Moderation is key here. What are the potential negative effects of consuming jeera?.

1. Rapid lowering of blood sugar levels

Jeera has a profound ability to reduce blood sugar levels because of the nutrients it contains within. Diabetics and pregnant women especially, take note. Never take too much at once, and always back off and enjoy your drink with less jeera if in doubt. Your medical provider might recommend that you reduce or cease drinking jeera water during pregnancies or if you have diabetes, and that’s one thing you must never disobey. Consult your doctor if jeera water is all right for you. Most people with generally okay health can consume jeera safely with no side effects.lowered blood sugar levels

2. Jeera might hamper breast milk production

Your medical provider might recommend you to stay away from jeera. There is a rare but possible condition where excessive amounts of jeera can result in lower production of breast milk. If you suspect this is the case, cease jeera water immediately and consult your doctor.

Summary

Jeera water is a simple, safe, all-natural and healthy drink. It is easily accessible to most people, and nearly no one experiences its side effects. The fantastic benefits it offers are available to everyone, as long as it is consumed in moderation and consistency, in the long run, will give you safe, dependable, steady results in improving your overall health.

It is time-tested from the ages, is popular the world over and will never stop ceasing to offer that refreshing cool tang the moment it touches your lips. Make it a part of a balanced diet and active lifestyle and watch your smile grow bigger every day with the safe, steady health benefits it offers.

Frequently Asked Questions

Q. What are the side effects of jeera water?

People with diabetes and bleeding disorders should be careful about the quantity of jeera being consumed. Having too much jeera water might lower the blood sugar level and affect one’s clotting mechanism as well.

Q. Can we drink jeera water in the night?

Yes, jeera water can be taken anytime of the day.

Q. How does Jeera help with weight loss?

Jeera plays a role in digestion and keeps your gut clean. Better digestion improves metabolism and plays a key role in losing weight.

Q. Will jeera water reduce belly fat?

Jeera water will not help specifically in reducing belly fat. However, by improving metabolism, it helps in overall fat loss combined with other factors.



[ad_2]

Source link

Categories
NEWS

Let’s make Narcan the CPR of a new generation

[ad_1]

In the 1990s and early 2000s, as heart disease became a major public health concern, millions of Americans voluntarily trained to administer cardiopulmonary resuscitation or CPR. In fact, the American Heart Association still trains more than 12 million people each year in this life-saving procedure.

Today, we are in the throes of an equally alarming public health crisis—the deadly opioid epidemic. With tens of thousands of American lives lost each year to drug overdose, it’s critical that we begin training Americans to administer Narcan (naloxone), just as we did with CPR, to help save the lives of our neighbors, family members and friends.

Issuing the first Surgeon General’s advisory in 14 years, Surgeon General Jerome Adams has urged every American to carry and be trained to administer this life-saving drug. In a recent interview with NPR, Adams said unequivocally, “We should think of naloxone like an EpiPen or CPR. Unfortunately, over half of the overdoses that are occurring are occurring in homes, so we want everyone to be armed to respond.”

While I encourage everyone to take a CPR course, performing CPR properly can be challenging for those who do not do it routinely, especially in a moment of crisis. In addition, only about 45 percent of all victims survive even with CPR outside the hospital.

In contrast, administering naloxone (Narcan) is relatively easy for non-medical personnel, and giving it quickly after an opioid overdose rapidly reverses respiratory depression – the primary cause of death. It is extremely safe, effective, and works in seconds. There are two simple delivery mechanisms currently available in the U.S. – an intramuscular auto-injector (like the EpiPen), and a nasal spray. Today, 49 of 50 states have standing orders allowing anyone to buy and administer Narcan without a prescription. As the drug epidemic has grown, Narcan has saved an untold number of lives, including over 17,500 cases in New York alone last year.

Who exactly should carry Narcan? The same people who should carry an EpiPen: anyone who’s around someone who might need it. And, in today’s opioid crisis, that’s nearly everyone.

Certainly, employers and school administrators should have staff trained and supplied with Narcan. According to the Bureau of Labor Statistics (BLS), overdose deaths at work from non-medical substance use jumped by at least 38 percent annually between 2013 and 2016. Some school districts are making it mandatory for all public schools to stock naloxone.

While there’s some controversy over making Narcan so readily and widely available, the reluctance is based mostly on the stigma associated with addiction and mental health issues, and an overall lack of understanding about how addiction impacts an individual and the community. The truth is, addiction and overdose can affect anyone. It doesn’t discriminate based on income, gender, ethnicity, or background.

It also doesn’t help that many drug users don’t realize the risk. Often, heroin or cocaine are laced with the deadly drug fentanyl, which is 100 times more potent than heroin, and drug users may have no idea. With fentanyl in the picture, “You’re injecting yourself with a loaded gun,” according to Tim Pifer, director of the New Hampshire State Police Forensic Laboratory.

That’s why we need to be prepared. Every day, more than 130 people in the U.S. die from opioid overdoses, which killed more than 47,600 people last year alone. This is an urgent problem, one that’s killing our neighbors, our friends, our family members, and our communities.

But we can help one other. Go to your local pharmacy and ask for a Narcan kit. It is covered by most major insurances. The pharmacist will train you in proper administration – it’s easy, and there’s very little risk of doing it wrong. Carry it with you at all times and hope you never have to use it. But know that you could be the difference between life and death for someone if you do.

Photo: Moussa81, Getty Images

 

 

[ad_2]

Source link

Categories
NEWS

Limit placebos in cancer drug trials to certain cases, FDA advises drugmakers

[ad_1]

Companies running randomized, controlled clinical trials of new cancer drugs should only use placebo controls in very select circumstances, according to a new guidance for the industry from the Food and Drug Administration. As a guidance, it is not binding, but nevertheless formalizes ethical principles that have existed for decades, drawing praise from a bioethics expert.

In particular, the FDA said, trial sponsors should consider only using placebo-controlled designs in circumstances such as when surveillance of the patient is the standard of care or when a trial uses an add-on design, whereby patients receive placebo in addition to an established treatment.

To be sure, oncology trials tend to involve a standard of care or best available therapy plus a new drug or placebo, whereby patients may receive the new drug or placebo in addition to a commonly used chemotherapy combination or one of a set of therapies from which the physician can choose. But the guidance is particularly important from an ethics perspective, said Jennifer Miller, a bioethics professor at Yale University.

“The issue here is that if you have a serious or life-threatening condition where there’s an available therapy, you should be able to get access to that,” she said in a phone interview.

The ethical principles governing the use of placebo in clinical trials go back to the Declaration of Helsinki, which the World Medical Association enacted in 1964 and was most recently updated in 2013. Generally speaking, a new intervention must be tested against the best proven intervention. However, placebo is permissible in cases when no proven intervention exists; there is a compelling scientific or methodological reason to use any intervention less effective than the proven one; and there is no additional risk of serious or irreversible harm to the patient.

“This principle has been around from an ethics perspective for a while, as enshrined in the Helsinki Declaration,” Miller said. “So it’s good to see it make its way into an official FDA guidance.”

Still, while the idea of comparing a new intervention against a standard of care may seem straightforward enough, Miller said ethicists have debated what it means to have a standard of care because there may not be routine access to that in many emerging markets. In such cases, she said, the ethical thing for drugmakers to do is to offer the U.S. standard of care in clinical trials, even in countries where it may not be available, given that they have the funding and capability to do so.

The guidance went on to list factors companies should take into account when considering a placebo-controlled study. First and foremost, they should provide a rationale for using such a design, especially when it involves something like a sham surgical procedure in which invasive methods are needed to administer a placebo, when prophylaxis is required for adverse events, when a therapy is available or when placebo is given by itself. While it is generally considered advisable to unblind patients and investigators in the event of disease progression or recurrence or a drug-related adverse event, the guidance stated that if trial sponsors intend to maintain patient-level blinding, informed consent documents should acknowledge the added risk and provide justification for it. Moreover, trial protocols and statistical analysis plans should include detailed descriptions of the proposal for blinding and planned unblinding.

Photo: FDA, Flickr (free of copyright protection)

[ad_2]

Source link

Categories
FITNESS

Barry’s Bootcamp Prices 2019 | POPSUGAR Fitness UK

[ad_1]

tmp_ao38Uh_e8be2969ba8e43f4_tmp_Ih2kSg_b289c1f2b14ba32a_Barry_s_Bootcamp_Studio.jpg

Barry’s Bootcamp is one of our favourite workouts because of how intense and thorough it is. We love a good sweat sesh! If you’re looking for a new fitness class to try in 2019, why not give one of the old reliables a chance if you haven’t already? Whatever your fitness goals might be, trying a new group fitness class to burn some calories is always a good idea. If you want to give Barry’s Bootcamp a shot, here’s what you need to know before your first class, including how much you can expect to pay.

What Is Barry’s Bootcamp?

Barry’s Bootcamp is incredibly popular in the U.S. and has three locations in the U.K. — all in London. It’s the ultimate high-intensity workout that combines cardio with strength training. You have two class options: Original and Double Floor. Following the Original format, you’ll split your time between running on the treadmill and weightlifting; Double Floor allows you to remove the treadmill from the equation and focus entirely on strength training.

The studios have a signature red-light treatment — so it’s a little dim — which keeps you focused on your workout and no one else’s. The music is also cranked up so there are minimal distractions, and you’re just hearing that on top of your instructor’s encouragement.

What Is a Typical Barry’s Bootcamp Class Like?

An Original class is 50 minutes long, with 25 minutes on the treadmill and 25 minutes of strength training, while a Double Floor class devotes the entire 50 minutes to strength training alone. Each class will vary based on who your instructor is and what music they’ve chosen, but expect a really high-intensity workout that will keep your body moving at all times.

Barry’s Bootcamp classes are for everyone, despite being pegged as a difficult workout. You can adjust the exercises to meet your needs and work at your own level and pace. And while there’s a heavy focus on pushing yourself in the weight training, you are encouraged to lift weights that feel right for you to get the most out of your workout. Still, each class burns up to 1,000 calories and produces a lot of sweat, so remember to drink plenty of water.

How Much Do Barry’s Bootcamp Classes Cost?

Typically, Barry’s Bootcamp pricing varies by region, but in London, each studio is priced the same. The cost per class varies depending on whether you choose to pay for a single class, or opt for one of their monthly membership options. Prices start at £22 per class. You can also buy packs of classes to reduce the cost per class; for instance, a 10 pack of classes will cost you £198. The membership packages have three options — each are allocated a set number of classes that must be used withing a 30 day period. For example, a 12 class monthly pack costs £211, and a 30 class monthly pack costs £325.

What Else Do I Need to Know?

Barry’s Bootcamp rotates its schedule every day, so you can, in theory, work out several days in a row and target each area of the body. Mondays are arms and abs; Tuesdays are lower-body focused; Wednesdays are chest, back, and abs; Thursdays are abs and butt; Fridays are total body; Saturdays are upper-body focused; and Sundays are total body.



[ad_2]

Source link

Categories
NEWS

FDA issues warning about hepatitis C drug as dozens of patients experience worsening liver function

[ad_1]

graphic design of a liver

Several dozen patients taking certain drugs for hepatitis C have experienced liver problems – some leading to liver failure and death – prompting the Food and Drug Administration to issue a warning against their off-label use in patients with poor liver health.

On Wednesday, the FDA said that 63 cases of worsening liver function known as liver decompensation were reported to its Adverse Event Reporting System, or FAERS, or found in medical literature. The FAERS collects reports of potential side effects from healthcare professionals, though the side effects may or may not be connected to particular drugs. The drugs included in the Wednesday warning were AbbVie’s Mavyret (glecaprevir/pibrentasvir), Merck & Co.’s Zepatier (elbasvir/grazoprevir) and Gilead Sciences’ Vosevi (sofosbuvir/velpatasvir/voxilaprevir).

The agency added that most of the patients had moderate to severe liver impairment and should not have been prescribed those three drugs, as they are not indicated for patients with those conditions. Legally, doctors are free to prescribe drugs off-label within the constraints of medical ethics and insurance coverage, though manufacturers cannot market their drugs for uses outside their FDA-approved labels.

Given that the reported cases came from FAERS and the literature, there may be many additional cases as well, based on the estimated 72,000 patients who received the drugs last year, the FDA said. Symptoms resolved in most patients after they stopped the medicine.

Collectively, the three drugs belong to a class known as direct-acting antivirals, or DAAs, which are designed to inhibit nonstructural proteins that the hepatitis C virus depends upon for replication.

In the context of compensated liver disease, they are “incredibly safe and effective,” wrote Dr. Kristen Marks, an infectious disease specialist at NewYork-Presbyterian Hospital, in an email. The important take-home point, she wrote, is early testing and treatment, as there are simple and reliable tests that can determine which patients can be safely given the drugs – a category into which the vast majority of HCV patients fall.

“In certain situations where these medications are the only drug options for potential cure, and liver transplant is not feasible, providers would weigh the risks and benefits of off-label use in the context of the particular patient and their goals of care,” she wrote. “For patients with cirrhosis and evidence of liver decompensation who have other options, options that do not contain a protease inhibitor medication should be chosen.”

Dr. Susanna Naggie, an infectious disease specialist at Duke University who has taken part in clinical trials of various DAAs, including the ones included in the FDA warning, concurred.

“Providers must be diligent to ensure they are adequately staging patients for liver fibrosis and liver disease severity before choosing a DAA regimen,” she wrote.

Photo: eranicle, Getty Images

[ad_2]

Source link