Statins seen providing no benefit for 50 percent of patients

Millions of patients do not benefit from taking statins and fail to achieve a cholesterol level low enough to reduce their risk of heart or stroke, report researchers.

According to a study recently published in the journal Heart, around half of people who are prescribed the drugs do not see their cholesterol drop to a healthy level within two years.

In the UK, around 150,000 people die from cardiovascular disease every year. One known contributor is low-density lipoprotein cholesterol or “bad cholesterol,” which can build up in blood vessels and form plaques that narrow them.

Reducing consumption of saturated fat can help to lower a person’s bad cholesterol, but some people also need medication and around six million individuals in Britain are prescribed statins for this reason.

Guidelines from the National Institute for Health and Care Excellence (Nice) state that the aim of the treatment is to reduce low-density lipoprotein cholesterol by 40% or more. However, in the current study, half of the patients did not achieve this target and were at a 22% greater risk for developing cardiovascular disease than those who did achieve the target.

Associate medical director at the British Heart Foundation, Professor Metin Avkiran, says that statins are an important and proven treatment for lowering cholesterol and that although the study suggests not all patients benefit from taking them, it does not explain why.

Experts say possible explanations include patients not taking their prescribed drugs or doctors prescribing doses that are too low.

For the study, Stephen Weng and colleagues from the University of Nottingham looked at 165,411 individuals (aged an average of 62 years) who had been prescribed statins between 1990 and 2016.

The team found that 84,609 (51%) of the patients did not see their cholesterol drop by the required 40% or more, even after having taken the medication for 24 months.

After adjusting for factors such as age and any ailments prior to treatment, patients who did not achieve the target were 22% more likely to develop heart disease than those who did reach the target.

Weng and team say the findings provide “real world evidence” about statins and contribute to the debate on the effectiveness of statin therapy. They also “highlight the need for personalized medicine in lipid management for patients.”

Commenting on the finding that many patients had a “sub-optimal” response, Avkiran suggests “it may be that these people have been prescribed low dose or low potency statins, that they are not taking the medication as prescribed, or that they are not responding well to the type of statins that they have been prescribed.”

Indeed, the researchers did also find that a higher proportion of patients who had a “sub-optimal” response had been given lower-potency doses, compared with those who had an “optimal” response.

We have to develop better ways to understand differences between patients and how we can tailor more effective treatment for those millions of patients who are simply blanket-prescribed statins.”

Avkiran says that people who have been given statins, should continue to take them regularly, as prescribed, and should discuss any concerns about their medication with their GP.

“There are now other drugs available to help lower cholesterol levels, and it may be that another type of medication will be an effective addition or alternative for you,” he suggests.

Are statins right for me?

Statins work by inhibiting CoA reductase, the enzyme responsible for the synthesis of cholesterol in the liver. They have been proven to reduce “bad cholesterol” in the blood, high levels of which have been linked to heart attacks, stroke and peripheral artery disease.

Statins are commonly prescribed to patients with hypercholesterolemia (high blood cholesterol levels) and are usually prescribed at high doses.

Some patients choose to come off statins, due to their side effects. These include: muscle pain, liver damage (rare), increased blood sugar (statins have been linked to an increased risk of type 2 diabetes), memory loss or confusion.

Reducing cholesterol naturally can be difficult, below are some suggested actions:

• Become more active – lowering blood cholesterol can be achieved through mild-moderate exercises, and even walking.
• Improving your diet – in addition to weight loss, lowering the amount of sodium (salt) containing foods and drinking less alcohol has been shown to reduce cholesterol levels.
• Quitting smoking – smoking cessation has been linked to improved HDL
• Meditation – stress increases blood pressure and can cause us to consume foods that are rich in triglycerides. Learning meditation techniques can reduce cravings and lower blood pressure, reducing the risk of cardiovascular disease.

https://www.news-medical.net/news/20190416/Statins-provide-no-benefit-for-50-percent-of-patients-say-researchers.aspx

CMS launches ‘comprehensive review’ of nursing homes regulation

CMS Administrator Seema Verma details a five-point plan to improve quality of care and regulatory enforcement at the nation’s nursing homes.

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KEY TAKEAWAYS

CMS Administrator Seema Verma calls for more coordination of nursing home oversight with state survey agencies.

HHS is requesting an additional $45 million in the FY 2020 budget to strengthen nursing home enforcement.

Verma pledges to improve transparency, quality and compliance without undue paperwork burdens on nursing homes.

The Centers for Medicare & Medicaid Services has launched a review of regulations and processes governing safety and quality of care in the nation’s nursing homes, Administrator Seema Verma said.

“While we support and promote the private sector’s critical role in our healthcare system, CMS’ duty to monitor the safety of the nation’s hospitals, nursing homes, and other providers, is a unique governmental task which lies at the core of government’s role in healthcare,” Verma said in a media release.

“I have directed my team at CMS to undertake a comprehensive review of our regulations, guidelines, internal structure, and processes related to safety and quality in nursing homes,” she said.

CMS will work with state survey agencies to oversee nursing homes. The SSAs visit and survey every Medicare and Medicaid participating nursing home in the nation at least annually to ensure they are meeting CMS’ health and safety requirements as well as state licensure requirements. To be effective, SSAs must be fair and consistent in applying CMS rules, Verma said.

Enhance Enforcement

“We’re strengthening our enforcement policies to hold nursing homes accountable for the care they provide. As part of this effort, we’re developing new ways to root out bad actors and repeat offenders,” Verma said.

SSAs are conducting a portion of their unannounced after-hours and weekend inspections to focus on staffing problems during those times. SSAs will take appropriate enforcement actions against those facilities that fail to provide the required nurse staffing, Verma said.

“We’re also improving quality of life for nursing home residents. Too often, residents with dementia-related psychosis have been deemed to be unruly or difficult, and have been given antipsychotic sedative drugs in contravention of FDA guidelines. CMS has worked through our National Partnership to Improve Dementia Care in Nursing Homes to curb the inappropriate use of these drugs in nursing homes,” Verma said.

“We’re also committed to working with Congress to strengthen nursing home enforcement. The FY 2020 Budget also requests $442 million for Survey and Certification, a $45 million increase from the previous year,” she said.

Increase Transparency

We’re constantly working to make sure the information on Nursing Home Compare is as accurate and informative as possible. In April 2018, we incorporated data on nursing home staffing based from a new payroll-based journal (PBJ) system into Nursing Home Compare and the Nursing Home Five-Star Quality Rating System. The new PBJ data allows CMS to more accurately track staffing levels in nursing homes.

CMS has also increased public awareness of nursing homes failing to meet our minimum health and safety standards. “Now, instead of publishing notices in local newspapers, we’re publicizing instances in which CMS terminates our agreements with nursing homes due to poor quality on our website,” Verma said. .

Improve Quality

CMS is developing quality measures that score providers based on patient outcomes, not adherence to processes, Verma said.

CMS fines nursing homes that don’t comply and the agency recently launched an initiative to invest these Civil Money Penalty dollars in efforts to reduce adverse events, improve staffing quality and improve quality of care for residents with dementia.

Put Patients Over Paperwork

When administrative burden increases with little or no benefit, patients suffer because mountains of unnecessary paperwork keep providers from patients. Additionally, high administrative costs can make it difficult for facilities to operate, Verma said.

“We are developing our regulatory strategy in a way that puts patient quality and safety first while removing unnecessary burdens on providers that create staffing challenges and increase cost without increasing quality,” she said. “We want to make sure providers spend time caring for residents instead of completing unnecessary paperwork.”

https://www.healthleadersmedia.com/strategy/cms-launches-comprehensive-review-nursing-homes-regulation

HCA hit by Medicare for All talk

Shares of HCA Healthcare (NYSE:HCA), one of America’s largest for-profit hospital operators, are under pressure thanks to a proliferation of presidential candidates supporting Medicare-for-all legislation that might pass after the 2020 election. Investors worried about HCA Healthcare’s distant future pushed the stock down 10.4% on Tuesday.

The sums HCA Healthcare receives from Medicare and Medicare Advantage are significantly lower than established gross charges for the services it provides. The hospital operator also offers discounts to managed care organizations, such as UnitedHealth Group (NYSE:UNH), but the government nearly always wrangles a deeper discount than private insurance companies.

HCA Healthcare doesn’t report until Tuesday, April 30, but warnings from UnitedHealth Group about the catastrophe Medicare-for-all could lead to spooked a stock market already nervous about attempts to tear apart the Affordable Care Act (ACA).

This is a good time to remember that nothing changes quickly in healthcare. The ACA became law in 2010, but HCA Healthcare and its peers are still adjusting to the shift from pay-per-service arrangements to payments based on patient outcomes.

Existential fears of a healthcare policy shift in Washington that could suddenly squeeze everyone into Medicare seem overblown. If Congress continues to act like Congress and accomplishes very little, HCA Healthcare investors buying at recent prices could see some impressive gains. The stock has been trading at just 11.4 times trailing earnings, and it even began offering a dividend last year that currently has a 1.4% yield.

https://www.fool.com/investing/2019/04/16/heres-why-hca-healthcare-slipped-today.aspx

Workplace wellness programs don’t improve employee health: study

Although more employers are turning to workplace wellness programs to improve workers’ health and save on healthcare costs, a new study shows they aren’t improving health metrics.

Researchers found that workplace wellness participants exercise more, actively manage their weight and have other healthier behaviors than their peers outside of the programs. However, they don’t have lower body mass index, blood pressure or cholesterol, according to an analysis published Tuesday in the Journal of the American Medical Association. It’s the first large-scale, randomized clinical trial examining the causal health effects of the employee programs.

The study also found the programs did not result in a significant reduction in healthcare spending or utilization of healthcare services.

“These findings suggest that employers who may be thinking about investing in workplace wellness programs or people who manage public dollars that might be interested in workplace wellness programs perhaps should temper their expectations of such programs to generate a large return on investment in the short run,” said study co-author Dr. Zirui Song, assistant professor of healthcare policy and medicine at Harvard Medical School.

More than 4,000 employees of big box retailer BJ’s Wholesale Clubs participated in the study’s wellness program over 18 months. But there was little difference in productivity between the control and wellness program groups.

Song said it was possible that the study was too short to see a positive clinical difference or that the program’s impact was short-lived.

Other studies have found mixed results from workplace wellness programs. One trial published last year by the University of Illinois Urbana-Champaignfound no significant difference in the health or healthcare costs over one year. The researchers suggested participants likely were already healthy and had low healthcare costs.

Another study in Health Affairs from Song and Dr. Katherine Baicker, dean of the University of Chicago Harris School of Public Policy, found that medical costs were reduced by $3.27 for every $1 spent on wellness programs. Costs associated with absenteeism fell by $2.73 for each dollar spent.

Employers continue to buy into workplace wellness programs, in part thanks to Affordable Care Act incentives. The law increased the maximum award employers can give employees if they participate in the initiatives.

In 2018, 82% of large firms and 53% of small employers across the country offered a wellness program, according to a Kaiser Family Foundation survey.

“It just makes sense that if my population does engage in healthy behaviors they will have healthier outcomes and they will be more productive,” said Mark Brittingham, CEO and co-founder of BSDI, a New Jersey-based corporate wellness technology provider.

Brittingham said the JAMA study results didn’t make sense since participants reported they exercised more but their health didn’t improve. He suspected their activity may have been overreported.

“No company should feel that they can just go drop a wad of cash on a program like this and magically get a reward in terms of medical savings over the short term,” Brittingham said. “Any vendor that says in 18 months we’re going to show you a huge return on your investment is simply not telling you the truth.”

https://www.modernhealthcare.com/safety-quality/workplace-wellness-programs-dont-improve-employee-health-study

Drugs could mimic gut bacteria benefits to treat diabetes

It may be possible to design drugs that mimic the positive health benefits of gut bacteria to treat diseases such as type II diabetes, a new study has found.

It is known that bacteria in the gut can provide positive health benefits, but so far the mechanism by which gut bacteria works has been unclear.

Scientists think one possibility is that gut bacteria, by fermenting starches in food such as oats and pulses, produce compounds called short chain fatty acids (SCFAs). One of these SCFAs is acetic acid – the main component of vinegar.

Once produced, these SCFAs activate specific receptor proteins in our body and these receptors, once activated, can provide health benefits.

In a four-year study, an international team of scientists, led by the University of Glasgow, team used a combination of genetics and pharmacology to see if one of these receptor proteins – called short chain free fatty acid receptor 2 (FFA2) – when activated selectively by drugs, generated responses in the body that underpin the health benefits of gut bacteria.

Andrew Tobin, professor of molecular pharmacology at the University’s Institute of Molecular Cell & Systems Biology, said: “Through a clever genetic trick, we have been able to determine that the levels of glucose in our blood and fat in our bodies can be controlled by gut bacteria.

“This is done via a specific receptor protein in our body, and we believe that the positive health benefits of gut bacteria can be mimicked by drugs that activate this receptor protein.”

Professor Graeme Milligan, Gardiner chair of biochemistry, added: “By generating a genetically-altered mouse that contains a form of FFA2 that can be activated only by a drug, we found that FFA2 can control the speed of food moving through the gut, the release of hormones that can control glucose levels and the release of fat from fat tissue.”

The scientists believe that, not only can FFA2, which is normally activated by acetic acid generated by gut bacteria, control these key processes important for our health and well-being but, importantly, that this receptor protein could be a target for new drugs in diseases where our response to food intake is dysfunctional, such as in type II diabetes.

The paper, ‘Chemogenetics defines receptor-mediated functions of short chain free fatty acids’ is published in Nature Chemical Biology.

Drugs could mimic gut bacteria benefits to treat diabetes

Inovio HPV Therapy Shows Efficacy for Respiratory Tract Tumors in Pilot Study

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced its novel therapy INO-3106 against the human papilloma virus type 6 (HPV 6) demonstrated clinical efficacy in a study of two patients with recurrent respiratory papillomatosis (RRP). RRP is an HPV-associated disease that can cause noncancerous tumor growths leading to life-threatening airway obstructions, and occasionally progresses to cancer. RRP is primarily caused by two strains of HPV, HPV 6 and 11, which also predominantly cause genital warts. RRP may occur in adults (adult-onset RRP) as well as in children (juvenile-onset RRP) who are thought to have contracted the virus during childbirth. Currently, the disease is incurable and can only be treated by surgery to remove the tumors, which temporarily restores the airway. The tumor always recurs and the surgery must be repeated, usually multiple times a year.

Inovio’s pilot clinical study enrolled two adult patients with RRP and one adult patient with tracheal cancer, all positive for HPV 6. One patient with tracheal cancer discontinued the study prior to the completion of follow-up. In the two patients with RRP, their condition had required surgery approximately every six months to clear the tumor growths. Following their last dose of Inovio’s HPV therapy, both patients have been surgery-free, due to lack of tumor recurrence. One patient has not needed surgery for over two years; the other has been surgery-free for over one year. A complete study report is being prepared as a medical publication. Inovio plans to further develop INO-3106 as a novel non-invasive immunotherapy for the treatment of RRP, a rare, orphan disease, for both adult and pediatric populations.

This data was presented at this week’s Annual Meeting of American Association for Cancer Research by David B. Weiner, Ph.D., Executive Vice President and Director of the Vaccine & Immunotherapy Center at the Wistar Institute and Inovio’s co-founder.

https://www.marketscreener.com/INOVIO-PHARMACEUTICALS-IN-17937428/news/Inovio-s-Novel-HPV-Therapy-INO-3106-Demonstrates-Clinical-Efficacy-Against-Rare-Respiratory-Tract-Tu-28435352/

Kroger Starts Don Lee Farms Organic Plant-Based Burger in Over 8,000 Sites

Kroger®, the United States’s largest supermarket chain by revenue, will be stocking Don Lee Farms® Organic Plant-Based Burger in the meat section.

Don Lee Farms is announcing the introduction of its trailblazing Organic Plant-Based Burger in nearly 2,000 Kroger® markets. The burgers will be sold in the meat section at Kroger®, Ralphs®, Dillons®, King Soopers®, Fry’s®, QFC® and Fred Meyer®.

Don Lee Farms® Organic Plant-Based Burger (Photo: Business Wire)

Donald Goodman, President, Don Lee Farms, said: “Working with Kroger® has been a priority for us in our pursuit to expand to where our customers want us to be. With the addition of Kroger®, we are bringing the fastest growing burger of its kind to nearly 2,000 locations in the United States. With both private label and branded, we are now in over 8,000 retail markets.”

The family-owned food company, named by Women’s Health® as one of the best veggie burger brands, according to nutritionists, recently announced distribution in Publix® and a global expansion into 15 countries in Europe, South America and the Caribbean.

The popular organic burgers will be available in Kroger® in May and are currently available at Costco Wholesale®, Publix®, Wegmans®, HEB®, Stater Bros®, Tops®, Stop & Shop® and markets across the United States. Contact Don Lee Farms directly for availability in your area.

Organic Plant-Based Burger

The Don Lee Farms Organic Plant-Based Burger, made with a handful of organic plant-based ingredients, sizzles on the grill just like raw beef. The burger is organic, vegan, gluten-free and an excellent source of plant-based protein. The fastest growing burger of its kind is the only burger to qualify for USDA’s organic certification. VegNews®, the world’s number one plant-based magazine, named Don Lee Farms’ burger the top news story of 2018.

Since its launch, Don Lee Farms has sold millions of the Organic Plant-Based Burger to club stores, markets and on Amazon®’s Treasure Truck. CookingLight® proclaimed, “when a new ‘beefy’ burger by Don Lee Farms came to the market… we gamely decided to taste them against the other beef-like veggie burgers. And we liked them. In a side by side taste test, we preferred Don Lee Farms’ burgers.”

About Don Lee Farms

Established in California in 1982, Don Lee Farms is a family-owned food manufacturer and leading national supplier of organic and conventional food products. They are the leading national producer of organic veggie burgers. Don Lee Farms produces plant-based and meat proteins for retail, club, foodservice and school foodservice markets. Consumer products and end items are sold at major retailers nationwide such as Costco Wholesale®, Whole Foods Markets® and Walmart® under the Don Lee Farms label, private brands and under brands of their partners. For more information, visit www.DonLeeFarms.com or follow Don Lee Farms on Facebook and Twitter, @DonLeeFarms.

https://www.marketscreener.com/news/Kroger-Introduces-Don-Lee-Farms-Organic-Plant-Based-Burger-Now-in-Over-8-000-Locations–28435288/