MDR and IVDR in 2019: up or out, sink or swim

If you have any kind of medical product that you sell (or plan to sell) in the EU, read this post by Eric Vollebreght of Axon Legal. If you provide these products to patients in the EU, this is very good information.

medicaldeviceslegal

sink or swimHappy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of events relating to the MDR and IVDR, this is the year that reality will start catching up with you. This year will determine if a manufacturer goes up, or potentially out.

Why is 2019 so important? Read on, and you’ll agree with me that it is. First, take a look at the below diagram with the transition timelines, to which I have added my own embellishments (the red and orange rectangles):

schermafbeelding 2019-01-06 om 20.28.45

IVDs

IVD companies will be like: 2022 – so far away! Actually – no. 85% of the IVDs will need to be evaluated by notified bodies compared to 7% currently under the IVDD. This means that 85% needs to be IVDR certified by a notified body…

View original post 2,642 more words

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How to Read and Understand a Scientific Paper for Non-Scientists

Reading and understanding research papers is a skill that every single doctor and scientist has had to learn during graduate school. You can learn it too, but like any skill it takes patience and practice. First, it’s important to form a truly educated opinion on a scientific subject of interest and become familiar with current research in that field. This is the beginning, before being able to distinguish between good and bad interpretations of any research, on any topic.

Reading your first couple of papers may take a very long time, but be patient with yourself. The process will go much faster as you gain experience. Reading a scientific paper is a completely different process from reading an article about science in a blog or newspaper. Be prepared to take notes and re-read. Primary research is the main focus here; each article is a peer-reviewed report of new research on a specific question (or questions) in that field. They are typically published in a well-regarded journal in that field. Most articles will be divided into the following sections: Abstract, Introduction, Methods, Results, and one or more Discussion/Conclusions/Interpretation.
This article has a nice 11-step process How to Read and Understand a Scientific Paper: A Step-by-Step Guide for Non-Scientists.  The author, Dr. Jennifer Raff worked it into a convenient .pdf, here How to read and understand a scientific article.

Importantly, this is not the only method to determine the validity and rigor of peer-reviewed science. We now have Retraction Watch; a site developed by science and medicine reporters that is gathering and evaluating the science papers that have been retracted from the journals (or experienced other negative actions) in which they were published. Until this site, there was previously no central repository of such things. They are working on a searchable database, but building that takes time.

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FDA seeking to stop procedures at two unregulated stem cell clinics

Federal health officials filed Federal injunctions Wednesday to stop two clinics from continuing to offer unproven stem cell therapies to patients, the most aggressive action taken in years. Two clinics — US Stem Cell, based in Florida, and California Stem Cell Treatment Center — were warned by the FDA in August that they had violated manufacturing procedures.

FDA seeking to stop procedures at two unregulated stem cell clinics – STAT

At US Stem Cell, a 2015 procedure led three women to go legally blind, California Stem Cell Treatment Center was involved in making an experimental cancer treatment from smallpox vaccine without any oversight. Another corporation (with over 100 clinics) Cell Surgical Network will also be affected by the CA injunction.

This issue has been building since Celltex, a Houston-based company received an FDA warning letter in 2012 because they were manufacturing stem cells without approval or inspection, not just mixing and administrating them (what clinics are allowed to do). Something called a BLA is needed to make a biologic drug (what stem cells are).

Next, they went after other clinics doing the same things (making products): Irvine Stem Cell Treatment Center, Miami Stem Cell Treatment Center, and Manhattan Regenerative Medicine Medical Group. As they investigated, the scope of the problem just kept building. Arriving at a Federal injunction (let alone two) takes a long time and a lot of evidence for an agency; the bar is set high to prevent government overreach.

Watch it with the stem cell therapies, folks. I know there’s a lot of excitement out there because of all the possibilities. Just because the proprietors of those clinics say they are within their legal rights and licensing to offer whatever therapies (and products) they see fit, does not make it necessarily so. Compounding pharmacies got into a whole lot of trouble (and killed and sickened a whole lot of people) a few years back for the same types of sloppiness and assumptions. Money and greed can induce people to do bad things; even doctors, even when a product is very cool and promising.

Duped patients crowdfund for bogus medical care

As stem cell scientist Paul Knoepfler puts it: “You should start getting worried if the clinic tells you that one kind of stem cell such as fat, bone marrow, or amniotic stem cells can treat many different conditions. There’s no science behind that kind of claim. Stem cells are not a panacea.”

If you’re truly interested in the evolving science and compliance behind all of this, here is some information.

Products under scrutiny: fat stem cells (adipose stem cells) and stromal vascular fraction (SVF).

In response to the fast pace of evolution on all things cell-based therapy, FDA created a Regenerative Medicine Policy Framework  they have issued several ‘guidances’ related cell-based therapies. There is one ‘draft guidance’ focused on commercial stem cell clinical products. Don’t listen to the folks with twenty-year-old gripes about how FDA doesn’t care about sick people or is in the pockets of industry. No large government agency is perfect or is completely immune to the industry they serve.

Some good sources of education:
Stem Cell Assays: Promoting Rigorous Reproducible Research on Stem Cells

The Niche: Knoepfler Lab Stem Cell Blog   SCOPE: What Are Stem Cells?

 

Boys Will Be Boys — Sex and The Perennial Supplement Recalls

 

You’ll see this over and over; ‘natural product’ companies promoting and selling “natural male enhancement” or “libido support” supplements, pills that really aren’t natural at all. They always have a secret ingredient. FDA calls them “undeclared active ingredients.”  So what’s the problem with getting a little boost in libido?

The big risk is that men with high blood pressure, high cholesterol, diabetes, or heart disease, or who may be on medications that, taken with one of these products, could lower blood pressure to dangerous levels that could be life-threatening. And the secret-ingredients are almost always adulterated, counterfeit or unlicensed erectile dysfunction drugs, typically produced in China or India by disreputable manufacturing shops.

counterfeit-drug-manufacturing-1024x576

Desmethyl carbodenafil, acetildenafil and hydroxyhomosildenafil  are all derivative of the blockbuster drug Viagra® (sildenafil citrate) that was being researched for relief of another indication (condition), angina pectoris, or chest pain–through relaxation of smooth muscle and increase blood flow. Also marketed as the lower-dose Revatio®, the drug’s effect on erectile dysfunction was an accidental discovery during an early clinical trial for chest pain. Cialis® (tadalafil) is a me-too drug that can be taken on a daily basis, rather than as-needed like Viagra. Both drugs work through activation of the nitric oxide (NO)–cGMP pathway which causes an inflow of blood which supports penile erection.

This is mechanism is somewhat similar to the illegal “poppers;” inhalants containing alkyl nitrates that also boost blood flow for the same effect (or a nice rush). These are typically volatile compounds initially intended for leather cleaners and industrial solvents have become popular recreational drugs; the dose is impossible to control. There are many reported incidents of overdose, especially among men with recent head trauma, bleeding into the head, glaucoma, or heart disease.

Want to get your groove back? There are some legitimate possibilities. There is some research (still a bit early, weak, or fuzzy) supporting aphrodisiacs and testosterone production enhancement. There are many testosterone booster products on the market, some may be legitimate, naturopathic doctors may know more about that. There are also physicians that will prescribe testosterone, natural or synthetic. There may be limited, long-term-use value from some herbs.

Any man that is interested in trying out an erectile dysfunction drug should mention it to his doctor. That will give him better information on risks and if they, in particular, have risk factors to think about before taking the drug. Once there is a prescription in-hand, check out the marketplace! There are brand names and Teva Pharmaceuticals plans to release its generic of the “little blue pill” as early as December. All can be ordered over the internet from reputable online pharmacies.

The obvious issue with most of these ‘natural male enhancement’ supplements or nutraceuticals is that they are NOT natural; in fact, no one knows what’s really in them because the undeclared drug might be impure, fake, or toxic, since they’re illegally produced. Even if the drug portion is pure, if you have risk factors and are unlucky, it can kill you. Young guys need to think about all this too. Have you been hearing about all the fentanyl overdoses? These are happening for two basic reasons. Addicted persons unknowingly using heroin laced with the incredibly-powerful drug and folks intentionally taking fentanyl but it’s a fraudulent/illegal version that is far more concentrated than the legally-produced version.

For the male enhancement fraud scheme, it’s not just FDA that is getting all up in their business. Australia’s TGA and Canada’s HC both are putting resources and attention into this issue, but with only marginal success. This is just part of a bigger scandal of adulterated supplements, mostly weight loss,  hair loss and erectile dysfunction. And that is just a fraction of the massive global crisis of counterfeit medicines.

So why is all this stuff still on the market? It’s about money of course; product demand versus agency testing and enforcement budget. “Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

money supplements

A search for such products (male enhancement supplement) for sale today on Amazon  showed 1,758 results, many of them the very same banned products on recall by the various regulatory agencies. There were also 64 results for male enhancement coffee, if you can believe that. And watch out for websites that purport to be consumer watchdogs like Supplements Watch, Male Health Review, The Supplement Reviews, or even Consumer Health Digest. All of them are clearly promoting products; they provide links to purchase them (always the kiss of death, pardon the pun).

As with all things dietary supplement, buyer beware. The U.S. has no regulations for supplement purity or potency and that is a big reason why we have this wild west market situation.

Other Sources:

Vegetable Vigra/Vegetal Vigra by Natures Supplement: Recall – Undeclared Drug Ingredient

Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall – Undeclared Drug Ingredients

Tainted Sexual Enhancement Products – FDA

Sexual enhancement products seized from stores – Health Canada

Counterfeit medicines and medical devices – Australia TGA

Oh well, these things just happen

We just had 59 people killed and over 500 injured at an outdoor concert with many more traumatized by the event. The guy who did this had purchased between 20 and 30 guns and no ‘background check’ flagged him from buying more. He was an ‘average guy.’ So now what?

Twenty children and 6 staff were killed at an elementary school in December 2012. Since then more than 150,000 people in the U.S. have died from gunshots. An average of 33,667 people die per year, including 1,520 mass shootings, that killed at least 1,715 and wounded 6,089.

It’s too hard to solve this, so let’s not really change anything.

Hey, as Bill O’Reilly says mass shootings are “the price of freedom.” Congress seems to agree. Congress Has Basically Done Nothing on Gun Control Since Sandy Hook Shooting. In fact, they have recently enacted legislation that could make events such as yesterday’s even more deadly.

Yes, other democratic advanced societies have mass-shootings occur. Scotland and Australia in 1996; Norway in 2011, France in the last few years. But only in the United States do they come again and again and again and again. No other society on the globe allows massacres to happen without a concerted government response.

If the founders of this country had been this gutless, we would still be an English colony.

If the Abolitionists of the 19th century were less courageous, we would still have legal slavery. If Suffragists in 1890-1920 had given up, women would not have the right to vote. If FDR had caved to massive political pressure and government and economic complexity, we would not have Social Security. I could go on, you know.

We can find a path to significantly reduce gun violence and fully-support the right of individuals as declared in the Second Amendment
  1. who can pass a national background check with all states complying,
  2. and obtain a license to purchase a standard handgun or rifle for personal or family protection and hunting,
  3. if he/she employs technology and physical barriers to prevent unauthorized users (children, mentally ill, intellectually disabled) from accessing the weapon.
    Federal laws should address all of these caveats.

Patriotism? How about we work to end these thousands of unnecessary violent deaths every year? Our gun violence is completely out of control; just look at this chart.

So what would it take?

Ask the Brady family, they started the fight.
  • If we had sensible national gun laws that required registration and a background check, that limited the number of guns a single person could accumulate (unless a registered gun dealer), and put more limits on the types of guns (ex. no semi-automatic) sold to the public.
  • If we had a national gun registry with purchase limitations that was linked to a universal database.
  • If all states participated in and contributed their law enforcement, purchase, and gunshot injury data to that database, equally.
  • If we allowed the nation’s public health system to collect and analyze gun injury and gun death data instead of defunding CDC and NIH research. The Docs are asking, begging for more gun violence data.
  • If we properly funded sufficient and qualified mental health care. Guess what? It’s Mental Illness Awareness Week. In Florida they even made it illegal for doctors to ask patients about guns in the house during a check up.

Speaking of rampant and difficult problems, we now have an integrated food safety reporting system and invigorated standards (thanks to the 2011 Food Safety Modernization Act) that holds food manufacturers and produce suppliers accountable and allows for rapid recalls to prevent massive outbreaks of food-born illness. Are the major food companies going bankrupt? Are their stocks all in the toilet? Have there been massive layoffs? The easy answer is NO.

Yet the system is in jeopardy at the moment; there are clearly not enough inspectors to deal with rogue companies creating more food hazards. What is the legislative response to this? Slashing the FDA budget while they double the defense budget seems to be the answer. In terms of your family’s health and well-being, which budget do you think is more likely to have an impact?

None of reforming our current gun violence epidemic is “impossible.”

When such a tragedy happened in Australia, they did something about it. So what about Australia? What do the data show? Do citizens there still own guns for hunting and self-protection? Yes, somehow they still seem to be operating as an open, democratic and ‘freedom-loving’ society.

It does take the will of the people and the fortitude of legislators to stand up to the intimidation and threats of the NRA and their funders. It would also be helpful if the average citizen could put just a little more effort into detecting ‘fake news‘ by just checking on the facts; they’re out there. Don’t count on social media and search engines to do it for you. As Thomas Jefferson wrote “an informed citizenry is the bulwark of a democracy.”

Don’t count on the Supreme Court doing the right thing.

Even though the 4th U.S. Circuit Court of Appeals in Richmond, Virginia, in an overwhelming Feb 2017 ruling upheld the Maryland assault weapons ban, saying they aren’t protected by the Second Amendment. Want to bet how the Supremes will vote with Gorsuch now on the bench?

The “Second Amendment has been the subject of one of the greatest pieces of fraud, I repeat the word ‘fraud,’ on the American public by special interest groups that I have ever seen in my lifetime.” -Chief Justice Warren Burger

That means if we actually value “freedom and democracywe might have to put forth some effort into staying informed. I’m betting most of you won’t, but I’m hopeful that you might change your mind.

I just hope that another 150,000 don’t have to die (quite possibly someone that you know), before we stop shopping, browsing, and playing games long enough to get informed, take a position, and hold our legislators accountable. Skeptical and still not convinced? Read this.

The links are fact and data-based articles, here are some other resources.
The Brady Campaign To Prevent Gun Violence is still one of the best non-partisan resources on policy strategy. (I hope you all recall that James Brady (R) was President Reagan’s first Press Secretary when he was shot in 1981.)
In lieu of adequate public health data being collected,

150,000 Americans killed by guns since Sandy Hook – Neritam

 

In the interest of the public safety debate, this is a straight up re-post from another blog.

– – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – –

In the less than five years since the horrific shooting at Sandy Hook Elementary School, 150,000 more Americans have been killed by guns – a number that is more than 30 times the number of Americans killed in the Iraq War. This year, death statistics went up by 88 deaths per day, which many agree is a conservative estimate. This is based on US Center for Disease Control data.

Sources:
150,000 Americans killed by guns since Sandy Hook – Neritam
150,000 AMERICANS KILLED BY GUNS SINCE SANDY HOOK- Stop Handgun Violence

Inactivated Shingles (Herpes Zoster) Vaccine Soon to Be Approved – Should Patients Wait for It?

A new shingles vaccine is soon to be approved that represents a real advance in prevention. Should patients wait for it?

This past week, an FDA advisory panel voted unanimously to approve it.

Shingles is a painful rash that usually develops on one side of the body, often the face or torso, in people who have recovered from chickenpox. People 60 years of age or older are urged to get a shingles vaccine.

The currently available vaccine (a live-attenuated zoster virus called Zostavax), has an efficacy (roughly, effectiveness) of only around 50%. This new inactivated zoster vaccine shows an efficacy of 97% in the first study, and 89% in the second. The incidence of post-herpetic neuralgia (pain) was also reduced.

So it won’t be just a “me-too” approval, but a real advance in prevention of what can be a truly debilitating, painful, and long-term condition. Approval should occur in the next couple of months, along with a critical review and recommendations from the Advisory Committee on Immunization Practices (ACIP).

Talk with your health care provider and decide what is right for your personal history.

Source: Inactivated Zoster Vaccine Soon to Be Approved – Should Patients Wait for It? – HIV and ID Observations HIV and ID Observations

Want to cut down on sugar consumption? What to use (and not use) instead

According to a 2014 study published by JAMA Internal Medicine, people who consume 10% or more of their calories from added dietary sugar have a 30% increased risk for cardiovascular disease related mortality. That risk is doubled for those who consume 25% or more of their daily calories from added dietary sugars.  The worst offender is sucrose (glucose + fructose), especially refined, white table sugar. It doesn’t really matter if it comes from sugar beets or sugar cane.

The sweet taste is not a bad thing. In fact, according to Ayurveda, there are six tastes that are all to be taken at each meal. A “balanced meal” is determined by the inclusion of all six tastes: sweet, sour and salty—which our culture loves—and bitter, pungent and astringent, which we in the West seem to avoid. According to Ayurveda, eating excess amounts of sweet, sour and salty foods causes the accumulation of kapha, which is directly linked to obesity, diabetes, cardiovascular disease, free radical damage and some cancers, to name a few.

I have found that the less sugar you eat, the less you crave it over time. It takes practice and patience, but you can lose that sweet tooth; and you will probably lose weight, help your teeth and gain health in the process.

So what can you use to satisfy that need for sweetness? Check out the alternatives.

Fructose molecule  HFCS

Fructose—A Safer Alternative?

Many “natural sweeteners” on the market today contain fructose as the sweet factor. Agave, for example, has a lower glycemic index than table sugar but is still a highly processed product that contains 90% fructose, compared to high fructose corn syrup, which is only 35-55% fructose. There are other considerations with corn syrup, however; it is the number one source of calories in the U.S. and is hidden everywhere, adding sneaky sugar calories where you’d least expect it.

Fructose may not spike insulin like table sugar, but it is still linked to diabetes, obesity, insulin resistance and high cholesterol. It is also a challenge for the liver to break down and, in excess, creates toxic metabolic waste products.

Stevia

The Stevia rebaudiana Bertoni plant was discovered more than 1,500 years ago by the native Guarani people, growing in clumps of two or three along the edges of the rainforests of Paraguay. In the beginning, the natives used the leaves for their medicinal benefit, to freshen their breath, and to sweeten and mellow the strong taste of herbal yerba maté tea.

These suppliers/brands have been evaluated by FDA and designated as GRAS (Generally Recognized As Safe) to be used as a sweetener:
– Sweet Green Fields
– Blue California
– McNeil Nutritionals
– Cargill
– Whole Earth Sweetner/Merisant

honey

Honey

While honey contains a whopping 47% fructose, it does have other redeeming qualities. Raw honey contains contains 18 amino acids, plus small amounts of many vitamins, minerals, flavinoids, and antioxidants which may reduce the risks of some cancers and heart disease. Because the bees add an enzyme that makes hydrogen peroxide, honey has anti-bacterial properties. These are not well-understood or fully characterized, but they merit more research. It may also have pro-immune and anti-inflammitory properties. Bee pollen or even simple honeycomb have been recommended by natural health practitioners for centuries, across the globe.

Honey is considered harmless for adults, but pediatricians strongly caution against feeding honey to children under 1 year old, the risk is infection with Clostridium botulinum which produces botulinim toxin, or botulism.

Sugar Alcohol Sweeteners

Sugar Alcohols (erythritol, glycerol (glycerin), hydrogenated starch hydrolysates—isomalt, lactitol, maltitol, mannitol, sorbitol, xylitol) are popular sugar substitutes, especially in processed foods, mints, toothpaste and chewing gum; they are naturally occurring in some fruits and are generally about half as sweet as sugar, unlike artificial sweeteners which are much sweeter. They are neither sugar nor alcohol, they just resemble their molecular structure. These sugar substitutes are not completely absorbed in the digestive system and can cause gas, bloating and diarrhea. They can cause an allergic reaction in those with sensitivity. Not truly sugar-free, they do contain some calories and carbohydrates.

Splenda

Splenda usually contains a small amount of mostly indigestible sucralose (trichlorosucrose) combined with 95% dextrose (D-glucose) and maltodextrin (by volume) which the body readily metabolizes. Dextrose and maltodextrin are GRAS because of their long history of “safe consumption.” Sucralose itself was given GRAS designation as a diabetic sugar substitute. However, its creation from sucrose is a synthetic chlorination process. There are outstanding questions about long-term use and McNeil Nutritionals, under McNeil Consumer Healthcare which also owns McNeil Laboratories, has a questionable reputation regarding suppression of consumer and patient adverse event data (think: toxicity of Tylenol).

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Artificial Sweetener and Their Risks

The food industry has created artificial sweeteners (such as saccharin, cyclamate, aspartame, neotame, and acesulfame ) that are hundreds of times sweeter than sugar, but calorie free. They have retail brands like Equal, Nutrasweet, SugarTwin,  Sweet ‘N Low, and Twinsweet. Accumulating evidence suggests that frequent consumers of these sugar substitutes may also be at increased risk of excessive weight gain, metabolic syndrome, Type 2 diabetes, and cardiovascular disease. There is a recurring theme of issues:

  1. They send a sweet trigger to the brain and never deliver any real energy; driving an even stronger message of hunger and desire for sweet.
  2. Most are made of excitotoxins that over-stimulate, exhaust and deplete the nervous system.
  3. Some are made of tiny amounts of known carcinogens (that are not GRAS).
  4. They have been found to actually increase weight gain, as they disturb metabolic hormones like leptin (appetite regulation) and insulin (glucose regulation).
  5. One (aspartame–phenylalanine and aspartic acid) can trigger behavioral and neurological disorders in phenylketoneurics.
  6. They may disturb (inhibit metabolic or excretion processes of) gut bacteria (probiotics).

Acesulfame K (Acesulfame Potassium)

Two hundred times sweeter than sugar, acesulfame potassium is a synthetic, no-calorie sweetener found in tabletop packets as Sunett or Sweet One, or in sugar-free gum, light juices, and light ice cream. It has been used in foods and beverages around the world for 15 years. The FDA says that more than 90 studies support its safety. Note that those were short-term studies.

Opposition to consumption of acesulfame K are based on the lack of long-term studies; it contains the carcinogen methylene chloride. Long-term exposure to significant amounts of methylene chloride can cause headaches, depression, nausea, mental confusion, liver effects, kidney effects, visual disturbances, and cancer in humans. At this time, the FDA has not required long-term studies.

Neotame

The top brand name is Newtame This sugar substitute is 7,000 to 13,000x sweeter than table sugar. This sweetener is chemically related to aspartame, but was modified to remove the negative issues associated with phenylalanine. Although there have been claims of over 100 scientifically based studies proving safety, one analyst was unable to find only a few studies that were not rat/mouse/dog short-term studies, looking into Neotame outcomes in very specific environments. The three studies done on humans found that participants suffered headaches, abdominal pains, diarrhea, and one had a backache. However, the participants were receiving doses far above the FDA approved intake for neotame.

So what to do?

How can you satisfy that need for sweet? All natural sweeteners are always a better choice; some have high carbohydrates (maple syrup, honey, coconut sugar, date sugar, molassesagave) and some don’t (mainly, stevia). You can start retraining your palette to enjoy the natural tastes of many foods, sweet or not. Try herbal teas, different roasts of coffee beans, or unsweetened chai (easy to find in Indian groceries). Eat dates or raisins with your hot drinks.

Try adding other flavors like spicy, tangy, tart, or savory to please your palette. Vanilla, almond, cardamom, cinnamon, nutmeg, mint, fennel, and turmeric all can add interesting taste dimensions; along with many vinegars, oils, and herbs. Balsamic glaze is a reduction of balsamic vinegar and adds an interesting and sweetened taste dimension.

 

Sources:

What to use instead of Sugar—and why Sugar is your Frenemy – elephant journal

The Truth About Sweeteners: Natural & Artificial – elephant journal

What refined Stevia preparations have been evaluated by FDA to be used as a sweetener? – FDA

Artificial Sweeteners – Medicine.Net

Top 4 Most Dangerous Artificial Sweeteners – FitDay

Top 10 Natural Sweeteners & Sugar Alternatives – Dr. Axe

Honey’s Unknown Benefits – Dr. Oz

Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. – Trends Endocrinol Metab. 2013 Sep

 

 

Doing THIS Before Bed Could Improve Your Sleep!

Yoga is a discipline that people of all ages and body types can enjoy. But to some, yoga can be a little physically challenging — not to mention intimidating.

However, you don’t need to be a human rubber band to enjoy the many benefits of yoga — like meditation, which can help lower blood pressure, relieve stress, and improve memory.

In an exclusive guide below, we go through 10 simple yoga poses that you can do right on your bed!

These “bedtime yoga” positions are the perfect nighttime routine, as they can ease stiff muscles and stressed minds.

Jessica Matthews, assistant professor of exercise science at Miramar College in San Diego, suggests finding the right type of stretches before you dive in. “One of the most important things is taking great care to understand what your body needs,” she said.

Source: I Had No Idea Doing THIS Before Bed Could Affect My Sleep! I Have To Try…

Ohio sues drug makers for spreading the opioid crisis

The lawsuit is only the latest to be filed by a local government as opioid painkillers continue to be blamed for fueling addiction and crime.

You can add Ohio to the list of state and local governments that are filing lawsuits against drug makers for spreading the opioid epidemic by allegedly downplaying risks and improperly encouraging prescribing of the addictive painkillers. Purdue Pharma, Janssen of J & J, Teva Pharmaceuticals, Allergan, and Endo International are being sued for false marketing including misleading ads in medical journals and the use of physicians and front groups to boost prescription sales.

I just want to know why it has to be the states and this was not dealt with by CMS and FDA. After all, they are the government oversight for patient health and safety under HHS.

Source: Ohio sues drug makers for spreading the opioid crisis