FDA Panel Unanimously Backs Cannabis Drug for Severe Epilepsy

 A US Food and Drug Administration (FDA) advisory committee has voted unanimously to support approval of a purified formulation of cannabidiol (Epidiolex, GW Pharmaceuticals) as an adjunctive treatment for Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients 2 years of age or older.

Although there are medications already on the market that include synthetic cannabinoid chemicals, if approved, this would be the first pharmaceutical formulation of a plant-based cannabinoid that maintains the mechanism of action of the chemical but without the "high" associated with marijuana, according to the manufacturer.

The Peripheral and Central Nervous System Drugs Advisory Committee had almost no concerns about the safety or effectiveness of Epidiolex, and congratulated the FDA, the manufacturer, and patients and families for having presented solid evidence.

"This is clearly a breakthrough drug for an awful disease," said panelist John Mendelson, MD, a senior research scientist at the Friends Research Institute, San Francisco, California.

"It's an honor to be part of a meeting that's making an important decision based on science and public input rather than a political discussion," said panel member Mark W. Green, MD, FAAN, professor of neurology, anesthesiology, and rehabilitation medicine, Icahn School of Medicine at Mt. Sinai, New York City.

"This is a historic moment," said Michael Privitera, MD, director of the epilepsy center at the University of Cincinnati, Ohio, who was an investigator for one of the pivotal studies. Privitera said he paid his own way to the meeting and receives no money from GW Pharmaceuticals. "We don't really understand how it stops seizures, but it's different than any other drug we've seen," he said, adding that it was rigorously studied.

"This will be more reliable than the dispensary marijuana that's available in many states," Privitera added.

The FDA usually follows its panels' advice. Billy Dunn, MD, director of the FDA's Division of Neurology Products, said the agency is "reviewing [Epidiolex] on an expedited timeline." The agency is due to make a decision by June 27. Epidiolex is also being reviewed by the European Medicines Agency, which accepted the company's application in February.

No Risk for Abuse

Even though Epidiolex is derived from marijuana (Cannabis sativa), it does not have properties conducive to abuse, said the FDA reviewers. That is crucial, because currently, Epidiolex is considered to be a Schedule I drug by the Drug Enforcement Administration (DEA). If the FDA approves Epidiolex, it will make a recommendation to the DEA that the drug be rescheduled.

If Epidiolex is rescheduled, GW Pharmaceuticals expects to make it available to physicians as soon as possible — most likely during the second half of this year — company CEO Justin Gover told Medscape Medical News. The company is proposing an initial target dose of 10 mg/kg daily, with dose adjustments up to 20 mg/kg, based on clinical response and tolerability.

One of the company's pivotal safety and efficacy trials in patients with LGS was published online January 24 in the Lancet. Data from that trial and two other pivotal studies were presented at the advisory panel meeting.

The primary endpoint — percentage reduction in drop seizures in LGS patients and percentage reduction in convulsive seizures in DS patients — was statistically significant for patients who received 14 weeks of treatment.

Brooklyn postal worker arrested after 17,000 pieces of undelivered mail found

A Brooklyn postal worker was arrested after 17,000 pieces of undelivered mail were found in his car, apartment and home, authorities said.

Aleksey Germash, a letter carrier who’s worked for the United States Postal Service for more than 16 years, had undelivered mail from as far back as 2005 in his possession. He told investigators he kept the mail because was overwhelmed by the amount he had to deliver each day. Germash said he made sure to deliver “the important mail.”

Officials found about 10,000 pieces of undelivered mail in his car, approximately 1,000 pieces in his locker and around 6,000 additional pieces of undelivered mail in his apartment.

They started investigating after they received information about full mail bags inside Germash’s car. USPS employees found 20 full bags in his car on April 18.

He was arrested April 19.

Germash is not the first postal worker to keep mail instead of delivering it. Agents arrested a Long Island letter carrier earlier this month after they found dozens of bags filled with undelivered mail behind his home.

Anyone who thinks they may have been a victim of mail theft or slow delivery can call 888-USPS-OIG or file a complaint online at USPSOIG.gov.

Alex Jones, Backtracking, Now Says Sandy Hook Shooting Did Happen

Talk show host Alex Jones has responded to a lawsuit from the parents of two children killed in the 2012 Sandy Hook Elementary School shooting in Newtown, Conn. Jones has repeatedly claimed on his website, Infowars, that the shooting was staged.

In a YouTube video, Jones said he now believes the shooting really happened, and that the families are being used by the Democratic Party and the news media. Jones invited the parents onto his program for a discussion about guns.

In the past, Jones has repeatedly claimed the shooting was staged and that parents of children who died in the shooting are actors.

The plaintiffs are the parents of Jesse Heslin and Noah Pozner, who were among the 20 students and six educators at Sandy Hook Elementary School who died in the shooting. They’re seeking at least $1 million from Jones. The lawsuit alleges Jones’s misinformation led conspiracy theorists to make death threats against the families of shooting victims.

The Mystery Of The Margate Shell Grotto (20 Pics)

In 1835 a labourer was digging a field just outside the English seaside town of Margate.  His work was interrupted when he thrust his spade in to the soil and it simply vanished in to the ground.  The master of the nearby Dane House School, James Newlove, was made aware of this strange disappearance.  He volunteered his young son, Joshua, for the task of being lowered, candle in hand, in to the void via a length of rope

Joshua’s tale was nowhere near as tall as people may have at first imagined.  When the hole was widened enough for adults to enter they too witnessed the wondrous contents of the winding subterranean passageway, complete with an altar chamber and rotunda.  Newlove senior, a canny schoolmaster if ever there was one, was first to consider the financial benefits such a discovery might reap.  He hurriedly purchased the land above the mysterious chamber and began to adapt it so that visitors might enter – for a small charge of course. In 1837, just two years after its discovery, the grotto opened to a curious public.  Yet to this day debate rages (in a very English way, of course, involving polite discussion over tea and cucumber sandwiches) about it origins.

How it came to be originally built remains unexplained.  However, the 2000 square feet of mosaics, created from mussel, cockle, whelk and oyster shells have provoked a multitude of explanations none of which have been confirmed with any total surety.

Shell grottoes of this type were extremely popular in the Europe of the 1700s. Many suppose that this was the result of a local bigwig embarking on the Grand Tour and returning with a desire to recreate a highlight of his or her European expedition.  Yet although this is not without the realms of possibility, the land above the grotto never formed part of any large estate, which is where you would expect such an extravagance to be positioned – close enough to the big house to easily chaperone curious guests to its confines. These visitors would be impressed both by the owner’s wealth and aesthetics because, frankly, this kind of thing was built to do both. 

Moreover, had the grotto been built in the 1700s then there would have been some vestigial local memory (or legend) of its construction.  In order to get millions of shells in to this underground passage many local people would have to have been involved in their transport.  Yet the discovery in 1835 was a surprise to all – no one stepped forward with any explanation.

It has been suggested that the grotto was a smuggler’s cave – almost all the shells are British and so it could have been a hideaway made by locals for stolen and contraband goods.  Yet this idea doesn’t hold much water either. Although near to the sea, the waves remain stubbornly a number of miles away and there are no tunnels from coast to ‘cave’. Plus with a distinct lack of an escape route any smuggler would have been mad to hide their booty here – not to mention the fact that they would have had to spend more of their time decorating the place than doing any actual smuggling. So, it’s a no to that theory as well.

Could it be a Roman temple?  A remnant of dark-age rituals?  A prehistoric astronomical calendar? Make up a theory and it could well be feasible – and many have.  There have even been séances held in the grotto to try and contact the spirits of the builders, such as the one from the 1930s above.

A number of the shells have been vandalised over the years by visitors.  Even though this is difficult to condone it adds an extra layer of history to the place.

The latest research which took place in 2006 points towards an explanation which might please Indiana Jones fans.  Mick Twyman of the Margate Historical Society put forward the suggestion that the grotto was built by the Knights Templar or their associates sometime in the middle 1100s.  He has suggested this after a painstaking measurement of angles inside the grotto (a temple now, perhaps?) and the way that the sunlight is projected in to the inside of the dome.   The altar chamber certainly looks the part of an early temple for masonic rituals. Yet this kind of theory, unlike its scientific namesake, isn’t proof – just conjecture however sensible and enlightened.

Why not get the shells carbon-dated?  This is certainly a possibility for the current owner (the grotto has always been in private hands although recent restoration work has been done in partnership with English Heritage, the charity that looks after the National Heritage Collection of the country).  However, this has been advised against for a number of reasons.  First and foremost quite a number of shell samples would be needed to ensure that dating caught the earliest shells and not just those used in previous (unknown) restoration work over the centuries.  Secondly it’s expensive and money needs to be more urgently spent on conservation rather than speculative investigation, however scientific and potentially illuminating.

How did the shells look before the decades of gas-lit exhibition and when water damage had not bleached them? A modern recreation of a panel from the grotto shows how it must have dazzled visitors in its heyday.

Yet, perhaps it is best to leave well alone in terms of a definitive origin story.  After all, even a secure dating of the oldest shells in the grotto would only establish their age – it would hardly go any further in discovering who built the grotto and why.  Sometimes it’s simply best to allow imagination to flourish and allow visitors to create their own history for this amazing place.

Family Adopts A Squirrel And Turns Him Into A House Pet (20 Pics)

Squirrels aren't usually the type of animals that people keep as a house pet but this family in Finland decided to take one in after they found him badly injured. They named it Arttu and he lived with the family for 6 happy years before he passed away.

The baby squirrel was found injured by the side of a road

“When it seemed like he had recovered, we tried to release him back to the wild but he fell from a tree and hit a rock”

“He survived, but we realized that his eye would never heal completely and he wouldn’t survive on his own”

“His name was Arttu (pretty much the Finnish version of ‘Arthur’)”

“We were very surprised how ‘tame’ he became”

“He liked to have playful ‘fights’ with our hands (you know, like cats do) and he was smart enough not to bite too hard”

“He also liked to take naps in our pockets”

“He even recognized his ‘family’ and became very wary if there were strangers nearby”

“[We fed him] nuts, fruits, berries and mushrooms”

Even when they let him go, he always came back – “He stayed there for a while and then jumped back to my shoulder”

“Squirrel’s claws grow all the time so we had to occasionally cut them because he couldn’t wear them out naturally”

The flash in this photo reveals the glow of his good eye…

…while this one shows his gray and cloudy blind eye

“He died of old age. One morning I found him dead, curled up in his ‘nest’ like he was sleeping”

Eat your greens raw for mental health benefits

New research has suggested that if you want to boost your mental health, eating raw fruit and vegetables could be more beneficial than cooked, canned and processed options.

Carried out by the University of Otago, New Zealand, the study set out to see if how we ate our fruit and vegetables could be just as important, if not more so, as how many we ate.

Although many public health campaigns have pushed the idea of aiming for five portions of fruit and vegetables a day in any form, the new findings suggest it could also be important to consider in what way produce was prepared and consumed, especially for mental health benefits.

For the study, the team looked at 422 participants aged 18 to 25 and living in New Zealand and the United States. They chose to focus on this age group as young adults typically have the lowest consumption of fruit and vegetables and are at a high risk for mental health disorders.

Participants were surveyed on their consumption of raw, cooked, and processed fruits and vegetables, as well as their negative and positive mental health, and lifestyle and demographic factors which could affect mental health such as exercise, sleep, unhealthy diet, chronic health conditions, socioeconomic status, ethnicity, and gender.

The team found that eating raw fruit and vegetables was associated with fewer depressive symptoms, higher positive mood, higher life satisfaction, and higher flourishing, which is a feeling of being engaged in your work and daily life and having a sense of purpose.

These mental health benefits were significantly reduced for cooked, canned, and processed fruits and vegetables, with eating processed fruit and vegetables associated only with a higher positive mood.

Lead author Dr Tamlin Conner believes raw food could be more beneficial for mental health as cooking and processing fruit and vegetables can diminish nutrient levels.

“This likely limits the delivery of nutrients that are essential for optimal emotional functioning,” she explains, adding that, “This research is increasingly vital as lifestyle approaches such as dietary change may provide an accessible, safe, and adjuvant approach to improving mental health.”

The top 10 raw foods related to better mental health were carrots, bananas, apples, dark leafy greens such as spinach, grapefruit, lettuce, citrus fruits, fresh berries, cucumber, and kiwifruit.

The results can be found published online in the journal Frontiers in Psychology. – AFP Relaxnews

 

Absorb These 14 Health Benefits of Vitamin C

You’ve been told many times by parents and doctors to get your Vitamin C… but why, exactly? Turns out it’s for more than fighting off colds, although that is reportedly 1-of the benefits.

When you consume Vitamin C from natural sources such as oranges, or take it with meals as a supplement, you’re giving your body a boost in many other ways. Let’s take a look at 14 health reasons to get your C…

1. An Iron-Clad Benefit

AuthorityDiet.com explains that taking Vitamin C can actually help you absorb iron better, which “plays a key role in forming hemoglobin, and also supports muscle and brain function.” It also helps you avoid anemia and feeling fatigued, it adds.

It cites a study that shows 280-mg of Vitamin C taken at breakfast will nearby double the amount of iron that your body absorbs on a daily basis.

2. A Solid Choice for Bones

When you think of bone health, you probably think about calcium first – and while it’s true that calcium is beneficial for bones and teeth, it’s not the only thing. WebMD published an article that says Vitamin C is good to the bone, in older men in particular.

The source cites a study that shows “a high intake of Vitamin C” may help reduce bone loss – the research uncovered higher bone density in the hips of men, but not the same benefit for women. This effect for men was most prominent at around 314-mg of Vitamin C from food or supplements (high above the recommended daily levels of 90-mg a day for men), it adds.

3. A Friend to Calcium

Speaking of calcium, apparently Vitamin C can also help your body absorb this essential element as well. Livestrong.com notes that consuming certain vitamins and minerals can have an adverse effect on the absorption of others, the opposite may be true when it comes to calcium and C.

The source says for that reason, you should blend your calcium supplements with a source of Vitamin C. “By drinking calcium-fortified orange juice, for example, you may be able to maximize your intake of both of these important compounds,” it notes. 

4. Giving Colds the Cold Shoulder

This is likely the benefit most associated with Vitamin C consumption, although as WebMD points out, “it may not be a cure.” However, that doesn’t mean you shouldn’t load up on C if you’ve already got the sniffles.

The source points out that some studies have shown consumption of the antioxidant vitamin can help prevent complications from a cold or flu, including developing pneumonia or lung infections.

5. You Can ‘C’ The Skin Benefits

Many people spend top dollar on skin creams and lotions to keep their skin looking young, and others go the extra mile for laser treatments to erase wrinkles. However, it turns out that just adding more C to your diet can help keep your skin looking supple.

The Telegraph explains Vitamin C was the “most searched” beauty product of 2017 – “widely known for its antioxidant benefits for your body but also your skin, brilliantly boosting collagen while helping to treat UV exposure photo-damage.” However, keep in mind the source touts Vitamin C enriched skin products, so you still might have to shell out some dollars.

6. Easier to Pee with C

We apologize for that headline (not really), but the point is that Vitamin C can help prevent urinary tract infections (UTIs), which can lead to painful urination. “If you have ever suffered from a urinary tract infection, you know it is an experience you never want to repeat,” notes AuthorityDiet.

It notes that doctors may tell patients to drink citrus fruit juices high in C to help acidify urine, which in turn will help limit unfriendly bacteria that causes a UTI in the first place. It may also be useful if you already have a UTI and want to limit the symptoms, it adds.

7. C is For Circulation

DiabetesHealth.com says taking a daily supplement of Vitamin C can be beneficial for healthy blood circulation – especially in patients that have type 2 diabetes, adds the source. “As a result, vitamin C may prove to be a potent combatant against diabetes-induced vascular disease,” it notes.

These diabetes-related vascular diseases can lead to complications such as retinopathy (which can lead to vision impairment and blindness), nephropathy (kidney problems), and atherosclerosis (causing excessive plaque build-up in the arteries).

8. Take the Vitamin to Heart

Many sources link Vitamin C intake with lowered risk of heart disease, but NaturalHealth365.com has some solid numbers to back up the claim – it cites a study published in Journal of the American College of Nutrition that says men who are in “the highest third of Vitamin C intake” have a whopping 66-percent less chance of developing coronary heart disease.

The exact reason for this heart benefit is unknown, but the source says scientists believe it may be linked to C’s ability to prevent endothelial dysfunction, which is the stiffening of arterial walls that can reduce blood flow – especially in patients that smoke, it adds.

9. Warding Off Alzheimer’s?

The Alzheimer’s Drug Discovery Foundation points out that Vitamin C may be good for more than fighting colds and helping your heart – it may help lower the risk of dementia, which is deadly in the case of Alzheimer’s Disease.

The source says “meta-analyses of observational research” shows diets rich in vitamins C and E are linked to up to a 25-percent lower risk of Alzheimer’s. However, the age and health status of subjects in each study varied, so the jury might still be out on just how much these 2-vitamins protect against dementia, if at all, it explains.

10. Dodging Scurvy

You might only think of scurvy as a disease that affected pirates travelling at sea during the age of discovery, but if not for Vitamin C, you could just as easily fall victim to this condition that causes fatigue, skin lesions, and bleeding gums. As AuthorityDiet notes, it can be lethal if untreated.

“Scurvy is the direct result of a lack of vitamin C, a relationship which is well-documented throughout history,” explains the source. Luckily, it takes about a month or so of little to no C for symptom to manifest, and that’s pretty unlikely to occur in a modern diet – unless you happen to be traveling around on a pirate ship. Those who have scurvy can essentially cure it by eating an orange.

11. ‘C’ The Benefits With Your Own Eyes

The American Optometric Association points out the benefits of Vitamin C relating to eye health, and says that “scientific evidence suggests vitamin C lowers the risk of developing cataracts.” Cataracts cause the clouding of the eye’s lens, which requires surgery to correct.

The source explains that smoking, diabetes and steroid use can all lower levels of Vitamin C in the eye’s lens, which can increase the risk of cataracts. It notes that “taken with other essential nutrients,” C can also help slow down progression of age-related macular degeneration (AMD) and visual acuity loss.

12. Stroke Another Risk Off The List

WebMD says although “research has been conflicting,” at least 1-study in the American Journal of Clinical Nutrition found those with the highest concentrations of Vitamin C in their blood had the lowest risk of suffering a stroke.

The source says the study found those with the highest levels of C have a 42-percent lower stroke risk than those with the lowest concentrations of the vitamin. “The reasons for this are not completely clear. But what is clear is that people who eat plenty of fruits and vegetables have higher blood levels of vitamin C,” it adds.

13. Improves Drive in the Bedroom?

If you’re looking to get a little boost in the bedroom, you could try some known aphrodisiacs such as oysters – but it turns out you don’t have to get that fancy, because Vitamin C is “a proven trick” to increase sex drive, according to the Huffington Post.

The source says that Biological Psychiatry found that “high doses” of time-released Vitamin C resulted in more “activity” (ahem), up from 4 to 14-times a month for most participants. Maybe there’s a reason those chocolate strawberries work so well – they are quite high in C (the chocolate is optional).

14. Muscling in On Aches

Here’s a pretty good reason to consume more Vitamin C, especially if you’re advancing in age and getting a lot more muscle pains than you used to, or you’ve been training for a marathon. Livestrong.com explains the vitamin “may contribute to reducing and relieving sore muscles.”

In particular, it talks about the benefits related to delayed onset muscle soreness from intense exercise that shows up 8-hours or more after activity. The pain is from damaged muscle tissue, and the duration of the pain is from healing of torn muscle fibers, it adds. However, the source says it’s most beneficial to take C supplements a short time before and after exercise, as regular supplements may not have any effect – and may even “prevent your body from adapting to exercise.”