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New Drugs Stir Debate on Rules of Clinical Trials

Brothers in clinical trial
© New York Times
Two Cousins, Two Paths Thomas McLaughlin, left, was given a promising experimental drug to treat his lethal skin cancer in a medical trial; Brandon Ryan had to go without it.
Growing up in California's rural Central Valley, the two cousins spent summers racing dirt bikes and Christmases at their grandmother's on the coast. Endowed with a similar brash charm, they bought each other matching hardhats and sought iron-working jobs together. They shared a love for the rush that comes with hanging steel at dizzying heights, and a knack for collecting speeding tickets.

And when, last year, each learned that a lethal skin cancer called melanoma was spreading rapidly through his body, the young men found themselves with the shared chance of benefiting from a recent medical breakthrough.

Only months before, a new drug had shown that it could safely slow the cancer's progress in certain patients. Both cousins had the type of tumor almost sure to respond to it. And major cancer centers, including the University of California, Los Angeles, were enrolling patients for the last, crucial test that regulators required to consider approving it for sale.

"Dude, you have to get on these superpills," Thomas McLaughlin, then 24, whose melanoma was diagnosed first, urged his cousin, Brandon Ryan. Mr. McLaughlin's tumors had stopped growing after two months of taking the pills.

But when Mr. Ryan, 22, was admitted to the trial in May, he was assigned by a computer lottery to what is known as the control arm. Instead of the pills, he was to get infusions of the chemotherapy drug that has been the notoriously ineffective recourse in treating melanoma for 30 years.

Even if it became clear that the chemotherapy could not hold back the tumors advancing into his lungs, liver and, most painfully, his spine, he would not be allowed to switch, lest it muddy the trial's results.

Roses

Juicing rare and unavailable strains of cannabis shown to benefit health

Juicing raw cannabis
© Karl Vick/Washington Post
Courtney juices carrots to cut the harsh taste of the ingredient, which is largely absent in psychotropic variety of cannabis.
The one-armed man loitered in the waiting room for much of the morning, flipping through magazines with impressive dexterity, quietly waiting for word that the doctor would see him. Now.

William Courtney, MD, offered the chair to the right of the desk, the one occupied during regular office hours by a steady stream of patients seeking a doctor's recommendation for marijuana. In California, such a recommendation means an adult may grow, buy and smoke marijuana, all while remaining safely within the confines of state law.

The singular peculiarity of Courtney's "pot doc" practice here in Northern California is what he recommends: Don't smoke the stuff, he tells patients. Eat it.

Marijuana, he avers to every person who appears before him, turns out to be brimming with healing compounds. It won't get you high eaten raw, but juiced with a handful of carrots to cut the bitter taste, its leaves and buds may well have restored the health of his girlfriend, who had been given a diagnosis of lupus and a butcher's bill of other disorders that lab tests show have subsided. A local sufferer of Crohn's disease credits the plant with helping reverse the debilitating intestinal disorder. And published research from accredited laboratories suggests promise in preventing diabetes, heart disease, Alzheimer's, cancers and assorted maladies arising from chronic inflammation.

Yet almost no one knows any of this beyond a handful of scientists
, including two at the National Institutes of Health who were sufficiently impressed that they joined a Nobel laureate in patenting a cannabis molecule. Courtney hands a copy of their U.S. Patent 6630507 to occupants of the chair, typically midway through a jargon-rich spiel that sometimes hits the patient right in the wheelhouse and sometimes goes whizzing overhead.

Comment: Cannabis Compound Halts Cancer
Marijuana Ingredient May Prevent Mad Cow Disease
Big Pharma Is in a Frenzy to Bring Cannabis-Based Medicines to Market


Arrow Up

Exercise Really Does Make You Clever: Fit Children Have Better Memories, Experts Say

Image
© Alamy
Physically fit children performed better in memory tests and had larger hippocampi, according to a new study.
If you want to boost your child's results at school, you could do a lot worse than ensuring that they do plenty of exercise.

Scientists have already shown that physical activity can make you brainier. But a team in America has used scans to show that an important part of the brain actually grows in children who are fit.

These youngsters tend to be more intelligent and have better memories than those who are inactive.

Scientists also found that one of the most important parts of their brains was 12 per cent larger than those of unfit youngsters.

Video

Video: From The Gulf Stream To The Bloodstream


When Is Enough, Enough?

For nearly five months, the BP oil disaster has consumed the minds of millions of people worldwide. In addition to the horrific impacts that the crude oil and chemical dispersants have daily on the environment and the economy, a fatal threat has quietly slipped by the public's proverbial radar. The harm dealt by this silent enemy is beginning to creep into the lives of those living and working in the Gulf. The problem has been lurking in the Gulf since the first days of the BP oil spill and now has the potential ignite a disaster unlike any this country has ever seen.

Attention

Groundbreaking Study Shows Roundup Link to Birth Defects

International scientists confirm dangers of Roundup at GMO-Free Regions Conference in Brussels

Glyphosate, the active ingredient in the world's best-selling weedkiller Roundup, causes malformations in frog and chicken embryos at doses far lower than those used in agricultural spraying and well below maximum residue levels in products presently approved in the European Union. This is reported in research (1) published by a group around Professor Andrés Carrasco, director of the Laboratory of Molecular Embryology at the University of Buenos Aires Medical School and member of Argentina's National Council of Scientific and Technical Research.

Carrasco was led to research the embryonic effects of glyphosate by reports of high rates of birth defects in rural areas of Argentina where Monsanto's genetically modified "Roundup Ready" (RR) soybeans are grown in large monocultures sprayed from airplanes regularly. RR soy is engineered to tolerate Roundup, allowing farmers to spray the herbicide liberally to kill weeds while the crop is growing.

Bulb

Why Meditate?

Image
If we take an honest look at ourselves, it is easy to see that we are a mixture of light and shadow, of good qualities and defects. One of the main obstacles we face is a deep-seated and often unconscious conviction that we're born the way we are and nothing we can do can change that.

Doing so, we significantly underestimate our capacity for change. Our character traits remain the same as long as we do nothing to change them. Yet, it is possible to arrive at a more optimal way of being.

Comment: To learn more about how meditation can help relieve the stress of everyday life visit the Eiriu Eolas - Stress Control, Healing and Rejuvenation Program website here.


Butterfly

Stop Paying Attention: Zoning Out Is a Crucial Mental State

clouds
© iStockphoto
I am going to do my best to hold your attention until the very last word of this column. Actually, I know it's futile. Along the way, your mind will wander off, then return, then drift away again. But I can console myself with some recent research on the subject of mind wandering. Mind wandering is not necessarily the sign of a boring column. It's just one of the things that make us human.

Everybody knows what it is like for our minds to wander, and yet, for a long time psychologists shied away from examining the experience. It seemed too elusive and subjective to study scientifically. Only in the past decade have they even measured just how common mind wandering is.

Some of the most striking evidence comes from Jonathan Schooler, a psychologist at the University of California at Santa Barbara who is one of the leading researchers on mind wandering. In 2005 he and his colleagues told a group of undergraduates to read the opening chapters of War and Peace on a computer monitor and then to tap a key whenever they realized they were not thinking about what they were reading. On average, the students reported that their minds wandered 5.4 times in a 45-minute session. Other researchers have gotten similar results with simpler tasks, such as pronouncing words or pressing a button in response to seeing particular letters and numbers. Depending on the experiment, people spend up to half their time not thinking about the task at hand - even when they've been told explicitly to pay attention.

MIB

FDA won't allow food to be labeled free of genetic modification

That the Food and Drug Administration is opposed to labeling foods that are genetically modified is no surprise anymore, but a report in the Washington Post indicates the FDA won't even allow food producers to label their foods as being free of genetic modification.

In reporting that the FDA will likely not require the labeling of genetically modified salmon if it approves the food product for consumption, the Post's Lyndsey Layton notes that the federal agency "won't let conventional food makers trumpet the fact that their products don't contain genetically modified ingredients."
The agency warned the dairy industry in 1994 that it could not use "Hormone Free" labeling on milk from cows that are not given engineered hormones, because all milk contains some hormones.

It has sent a flurry of enforcement letters to food makers, including B&G Foods, which was told it could not use the phrase "GMO-free" on its Polaner All Fruit strawberry spread label because GMO refers to genetically modified organisms and strawberries are produce, not organisms.

Family

Infant's gaze may predict autism

High-risk babies look less at caregivers

Infants frequently gaze at people's faces. It's as if they're fascinated and, perhaps, yearning for interaction with the people in their lives. Infants who don't exhibit this fondness for human faces, researchers say, may be exhibiting one of the first signs of autism.

With autism rates soaring over the past decade, researchers are seeking the earliest clues of the disorder. The sooner a child is diagnosed and begins treatment, experts say, the better the long-term outcome. In the September issue of the Journal of Child Psychology and Psychiatry, leading autism researchers say they think infant gaze is among the first clues of social functioning. A hallmark characteristic of autism is an inability to socialize.

Attention

The Role of Oxalates in Autism and Chronic Disorders

A mummy that had been preserved for a couple of thousand years in the high desert of Chile was discovered upon X-ray examination to have a very large oxalate stone in the kidney, about the size of a golf ball. The discovery of this ancient sufferer is testimony to the fact that kidney stones and oxalate toxicity have afflicted humans for a very long time.

Oxalates (the salt form of oxalic acid) are extremely painful when deposited in the body. About eighty percent of kidney stones are caused by oxalates and they are by far the most common factor in kidney stone formation. There is also a large degree of genetic variability in the ability to detoxify the chemicals that produce oxalates. Perhaps twenty percent of the population has a genetic variance that increases their likelihood of producing oxalates, even when not consuming a high-oxalate diet.