Wednesday, September 19, 2018

GERMAN RESEARCHERS FIND THAT SANDALWOOD STIMULATES HAIR GROWTH AFTER 6 DAYS

"Studies have already shown that exposing human skin cells to sandalwood in the lab causes the protein keratin to multiply, which speeds up wound healing."  That's neat.  So sandalwood oil has wound-healing capabilities in addition to stimulating hair follicles.  But the article ends with a funny insertion at the end.  In a kind of non-sequitur, it describes how lab animals were treated with a micro-lasers to reactivate hair follicles. 
This comes after research released earlier this week showed that a wearable device made up of 900 micro lasers stimulated hair growth in rats with alopecia.
Wearing the 20mm thick patch for just 15 minutes a day for less than three weeks caused the rodents to grow longer hair faster than those who received a standard hair growth injection. 
Although interesting, not completely sure of the relevance of lasters to oils except in the greater subject on the treatment of baldness.



Thursday, September 13, 2018

The Connection Between Cardiovascular Disease And Brain Shrinkage

The above Tik Tok video is from December 2021.  The 36-year-old woman was vaccinated on December 2, 2021. 
Here are the facts: 
1)  The victim's name is Candice Murley.  
2)  She was vaccinated TWO days before she passed:

The devastated sibling didn’t disclose the cause of Murley’s death. However, two days before she passed, the mother of one had uploaded an 8-second video in which she said, “I hate it when the voices in my head go silent because then I don’t know what those f – – kers are up to.”

So, more than likely, her cause of death was the vaccine.  In any murder investigation, investigators want to talk to suspects who were last seen with the victim.  In this case, it was the vaccine. 

So, within those TWO days, she reported that the voices in her head went silent.  "The 36-year-old mysteriously died Sunday, several days after claiming that the 'voices in her head had gone silent.'”

One, it should be a horrific shock that the woman, a 36-year-old woman dies unexpectedly, unexpectedly until you learn that she HAD THE VACCINE TWO DAYS BEFORE SHE DIED.  It's not so unexpected then, is it?  

For the family and friends, the death of a loved one is an unspeakable loss.  But losing the voices in her head is equally disturbing.  Those voices are the sign of creative energies, fun, entertainment, and one's mojo.  She said,
“I hate it when the voices in my head go silent because then I don’t know what those f – – kers are up to.”  So even though she was injured and had what amounted to a chemical lobotomy, she still retained a sense of humor.   
What happens in the brain of the vaccinated?  

Her death was unexpected because her family knew their sister and auntie as a very lively force for good and for fun.  What could've possibly taken that life from them?  Her sister uses the word "unexpected," because she doesn't know what to say.  There was no build-up of an illness that brought on her death.  The only thing that she did differently was get a vaccine TWO days earlier.  So, it's not so unexpected then, is it?  The sister, Marsha McEvoy, explained, 

“We have received some news no one wants to hear, tonight we lost a huge part of our family, my sister Candice,” wrote Murley’s sister Marsha McEvoy, confirming the star’s passing on GoFundMe. “This was very unexpected, and our hearts are torn apart. Candice was so full of life and always lived life her own way.”

What I'd like to know is what is in the vaccine that is killing brain cells or larger parts of brain mass?  Crickets.  All we hear from doctors is early treatment."  But not specifics.  And is this brain damage related to the ubiquitous reports of myocarditis?  Is this why the media is downplaying the severity of myocarditis in the living?  Kind of hard to do this with the dead.  Which means the cover-up continues.  Myocarditis is a severe condition if you do survive.  It has to have a limiting effect on the number of biological years, or life years.  Meaning your life is cut short.  The Mayo Clinic explains

Myocarditis is a potentially fatal inflammation of the myocardium that typically develops secondary to viral infection, often in young, seemingly healthy men. Its prevalence worldwide is estimated to be 0.5 to 4.0 percent, with reports of biopsy-proven myocarditis occurring in up to 16 percent of adult patients who have unexplained nonischemic cardiomyopathy. 

So myocarditis is a potentially fatal inflammation.  Nothing to sneeze at.  

I'd heard other stories that the vaccine killed the God gene in human beings.  Is this what they're talking about when people say that the voices are gone?  


I typed up an article a few years back and linked to an article by Dr. Barry Volk, called "The Connection Between Cardiovascular Disease and Brain Shrinkage," 
Even with the internet, it can be difficult to obtain actionable, accurate information, in large part, due to competing forces of information chasing the highest dollars.  Certain pharmaceutical companies control the information either through misrepresenting what works, burying what works, or dominating other markets like the vitamin supplement markets or even the prescription medication market.  So it is this shell game.  One of the best examples of this is a 5K or 10K or Marathon for Breast Cancer or Mental Health or AIDS, or pick your favored pink-ribbon catch-all.  When a disease or cause is introduced, its introduction is the start of a marketing plan that has been worked out months in advance by a limousine marketing firm, most likely found on Madison Avenue.  And these campaigns are fast and furious.  As if these conditions are impervious to a little B vitamin or a little extra B vitamin, like B-12 or B-1.  The organizations that run the races deliberately forbid any consideration or any announcement or note of a nutritional compound.  Instead, according to them, what you need is a pharmaceutical to fix things.  But the example that I like to cite is what Bill Sardi found is that fat-soluble B-1, Benfotiamine has the ability to cure Alzheimer's.  You'll never hear about it because the pharmaceutical industry controls the major publications, they've got millions to spend on TV ads.  I mean they just out dollar any company that is doing innovative research on bringing new or old but valuable products to market.  

The biggest factor in gaining information on what works, what doesn't, how much to take of this, what to avoid outright and what to avoid so that there are no contraindications is  There are mavericks who learn, study, discover, and breakthrough the narrative to find new or obvious information that should have been revealed decades ago.  Whether this protective effort is intentional or accidental, no one can argue that it exists.  Even a former Upjohn employee recognized this with regard to the relationship with the FDA and the pharmaceutical industry.  So what happens is that people die before they figure out what the problem is or how it should be treated.  And what keeps people from finding out is not for a lack of effort, for you hear all the time how folks spend years going to this and that doctor, who may even be misleading them down the wrong drug or therapy path.  So it is even with nutritional supplements.  Take Glucosamine/Chondroitin.  



It's a compound that is used to support joints.  A lot of young athletes sought it out, particularly basketball players whose joints were constantly getting pounded on the court, as a way to repair the cartilage and protect the tendons and replenish the synovial fluid.  But how many of us had heard of or had known that Chondroitin Sulfate, which is an isolated compound, has the ability to reverse heart damage.  What!  Reverse?  That's the claim.  What kinds of damage?  The kind that stroke patients or heart attack patients experience?  Yes.  That and much more.  Think about it--think about how your heart gets weakened or loses strength or in some ways suffers some kind of damage.  Believe me, this is not easy, in part, because the heart, as so many other organs and organ systems have in your body, has a back-up or compensating function.  So let's say that someone does have heart damage, how will you know?  Will your doctor find it?  How?  If he does find it, will he know its causes?  Does it matter--I mean compared to fixing the problem?  It matters somewhat because prescription medicine is design according to specific problems.  Isn't it?  Okay, so long story short, if you've not had the healthiest of lifestyles, if you've eaten junk food or fast food for too many years, or if you've consumed on a regular basis high glycemic foods, like wheat flour products (breads, tortillas, sandwiches, burritos, etc.) or rice or cakey deserts, you're weakening your blood vessels that your heart depends on.  It's true that your heart can pump, can produce despite the assaults to its integrity, but for how long?  At what point does the minute, imperceptible damage work its way gradually into a condition?  And once it becomes a condition, what then?  
Well, here's another wrinkle in this puzzle.  Brain volume shrinkage.  If you don't want your brain to shrink, you'll need to keep your heart in good health.  You don't want any of your lobes--temporal lobe, frontal lobe, occipital lobe, etc.--to shrink.  To avoid this, the heart has to function strongly to provide nutritional support to your brain.  If something happens to your heart or something happens to your brain, that reciprocal relationship between heart and brain is damaged.  You'll need support.  Ever witnessed the facial muscles or the face of elderly or injured folks and how pale they are?  That's because the reciprocal relationship between the heart and the brain is compromised.  But if you repair one, it will have benefits on the other organ.  

In "The Connection Between Cardiovascular Disease And Brain Shrinkage," Barry Volk explains that heart disease obstructs blood flow to the brain can cut off nutrients and cause it to shrink or lose volume.  The evidence for this is abundant, clear and present. 
When blood flow to the brain is restricted, your brain receives less oxygen and fewer nutrients, causing it to shrink. Studies show that people with lower levels of blood flow to the brain have smaller total brain volumes and total thickness of the cortex (the active surface layer of the brain)—resulting in poorer performance on tests of cognitive function.
Oh, and for those who think that you're out of the woods because you don't have heart disease, you'd do well to read this:
Even if you seem perfectly healthy, you may be losing as much as 0.4% of your brain mass every year. The rate of brain shrinkage increases with age and is a major factor in early cognitive decline and premature death.
It's easy to imagine the problems that arise with brain shrinkage--all o the functions that your brain is responsible are liable to dysfunction, things like your eyesight, your kidneys, circulation in the lower extremities, muscle reflexes, and so forth and so on.  This relationship between your heart and brain is, without coming off too dramatic, vital.  

And with brain shrinkage, come very specific catastrophic threats, like a stroke.  
Studies show that older adults with significant brain shrinkage are much more likely to have cognitive and movement disorders than similarly aged people with normal brain size. They are also at an increased risk of vascular death and ischemic stroke.
And it's not just the synergistic performance of all of your senses--sight, taste, hearing, smell, and feeling that are at risk with reduced blood flow to the brain.  There is the aesthetics of how you look.  Generally speaking, the less blood flow to the brain, the paler you're going to appear.  That's not going to bode well for your social life.  Even more disturbing is the emotional toll on individuals with reduced blood flow.  Their risk of depression goes up 181%.  Nice.  
In addition, atrophy of specific brain regions has been associated with a variety of cognitive, behavioral, and mental health problems. Shrinkage of the temporal lobes, for example, is associated with a 181% increase in the risk of major depression.
The point I am trying to make here is that if someone suffers damage to the heart or to the brain, know that the problems are not local to either organ.  The two organs, like all of your organs, are in a reciprocal, biofeedback loop.  They function in conjunction with other organs and not in isolation.  That should be clear but it doesn't hurt to state it because when we start to seek assistance in recovery we might start by getting inaccurate or incomplete information.  
Perhaps most alarmingly, brain shrinkage sharply increases risk of early death: 
Younger individuals with overall brain shrinkage have as much as a 70% increase in the chance of dying,
In a study of people aged 85, temporal lobe atrophy is associated with a 60% increase in the risk of dying.
Severe atrophy of the frontal lobe (behind the forehead) increases the risk of death by 30%.

There is nothing funny about brain shrinkage.  It's a death sentence.  Or you can adhere to the Walter White theory that, well, yeah but every life comes with a death sentence.  

Okay, so we know its bad.  But what are the options for protection or restoration?  Well, Barry Volk offers some terrific suggestions.  They are B vitamins, fish oils, Resveratrol, and pomegranate.  These are all good protective compounds.  And by protective, it means that you need to consume these on a regular basis if you want them to be so--if you want them to be protective.  But what about restorative?  What about rehabilitative?  What about therapeutic?  Perhaps for this pursuit, you'll need something more effective.  Just as gentle but something that targets the problem specifically and immediately.  Well, we know that Chondroitin Sulfate reverses heart damage.  Why not start there as a way to repair both organs--your heart and your brain.  If you repair your heart, the benefits on the heart will support the brain.  It is just that simple.  
Brains also shrink from the inside out, resulting in enlargement of the fluid-filled ventricles, or hollow spaces on the interior of the brain; such shrinkage has its own modest effect on early death.
Even though brain shrinkage is progressive, a growing number of neuroscientists believe that brain shrinkage can be slowed or even reversed.  (See footnotes 11-13 that support that claim.)  In this article, we will share with you how lifestyle changes and proper supplementation can help prevent this devastating cause of cognitive decline and premature death.
BRAIN SHRINKAGE IS NOT INEVITABLE
Like so many of the symptoms of aging, brain shrinkage was long thought to be simply an inevitable consequence of growing older. However, we are learning that brain atrophy is by no means inevitable. A host of conditions—from cardiovascular disease and diabetes to sleep and anxiety disorders to lifestyle choices—have been associated with brain shrinkage. Since many of these are reversible or at least preventable, it’s important to understand their impact on brain shrinkage, cognition, and lifespan.
THE CONNECTION BETWEEN CARDIOVASCULAR DISEASE AND BRAIN SHRINKAGE
Although we don’t often hear about this, there is a strong connection between cardiovascular disease and brain shrinkage.
Perhaps the most obvious connection is the one between blood vessel disease (atherosclerosis) and brain volume. Atherosclerosis occurs when plaque builds up inside your arteries and restricts blood flow throughout the body. Although we typically think of the negative effect atherosclerosis has on the heart, its effect on your brain can be equally devastating.
When blood flow to the brain is restricted, your brain receives less oxygen and fewer nutrients, causing it to shrink. Studies show that people with lower levels of blood flow to the brain have smaller total brain volumes and total thickness of the cortex (the active surface layer of the brain)—resulting in poorer performance on tests of cognitive function.
In addition, disease of the coronary arteries (the arteries that feed the heart muscle) is also associated with decreased brain volume. When compared to healthy controls, patients with coronary artery disease had significantly smaller gray matter volume in several regions of their brains.15 This is especially significant since gray matter is where all thinking, feeling, sensory, and motor function originates.
The relationship between cardiovascular disease and brain volume operates in both directions: People with smaller brain volumes have been found to have a 58% increase in the risk of death from all causes, a 69%increase in risk of vascular death, and a 96% increase in the risk of stroke, compared with those having normal brain volumes.10
Several other risk factors commonly associated with cardiovascular disease may also predict brain shrinkage. For example, people carrying the ApoE4 gene variant have significantly smaller overall brain size—with a specific decrease in brain areas that process memory and emotion.16
High levels of the amino acid homocysteine, another risk factor typically associated with heart disease, have now also been connected to brain shrinkage (independent of its impact on cardiovascular disease).
Specifically, studies have shown that people with high levels of homocysteine have smaller volumes of gray matter in the brain—and as a result, have worse scores on many tests of cognitive function.
This was especially evident in a study of a group of people who had recently suffered strokes. The researchers found that those with the highest homocysteine levels had a tremendous 8.8-fold increase in the risk of brain shrinkage (compared with those having the lowest). Other studies have demonstrated that the higher the level of plasma homocysteine, the greater the rate of brain atrophy and the risk for Parkinson’s and Alzheimer’s diseases.
A deficiency of B vitamins has also been tied to brain shrinkage. This makes sense since inadequate amounts of vitamins B6, B12, and folic acid can lead to elevated homocysteine levels. This occurs because these vitamins play a role in converting homocysteine into an important protein building block and when there’s a shortage of B vitamins, that conversion process isn’t as efficient, and homocysteine levels increase.
Close associations have been found between low levels of folate, for example, and severe gray matter atrophy and atrophy of the hippocampus, a main memory-processing center in the brain.24,25 Similarly, people with lower vitamin B12 levels have been shown to have progressive brain atrophy, with rates of brain volume loss 517% greater than those with higher levels.
Remarkably, it has been found that brain shrinkage due to high homocysteine levels must reach a critical level before cognitive decline sets in.21 This is another example of the “therapeutic window of opportunity” during which brain shrinkage may be prevented by adequate supplementation, as we’ll see later.

CONNECTION BETWEEN DIABETES AND BRAIN SHRINKAGE
Diabetes is notorious for causing problems with the peripheral nervous system,28leading to conditions such as painful diabetic neuropathy and blindness-inducing diabetic retinopathy. New findings suggest that high blood sugar levels—and the advanced glycation end products (AGEs) that they produce—cause damage to the central nervous system as well, specifically neurodegeneration and brain atrophy.
Studies have shown that, when compared to nondiabetic people of similar age, diabetics have an average of 4% smaller hippocampal volume, a nearly 3% reduction in whole brain volume, and double the risk of mild cognitive impairment.
In addition to causing brain shrinkage, studies now suggest that diabetes induces toxic, misfolded proteins quite similar to those found in neurodegenerative diseases such as Alzheimer’s, pointing to yet another way that diabetes can damage brain cells.34 Indeed, diabetes and Alzheimer’s disease share many properties, including defective insulin release and signaling, impaired glucose uptake from the blood, increased oxidative stress, stimulation of brain cell death by apoptosis,35,36 blood vessel abnormalities, and problems with energy production in mitochondria.

OBESITY AND YOUR BRAIN
Like diabetes, obesity is a known cause of brain atrophy.39 Even in people with normal cognition, higher body mass index (BMI, a measure of obesity) is associated with lower brain volume in obese and overweight people.
Obesity and diabetes share many similar mechanisms, including insulin resistance and oxidative stress, both of which are known to contribute to brain atrophy.38,41 In addition, fat deposits produce huge amounts of inflammatory signaling molecules (cytokines) that may contribute to brain cell death and brain volume loss.
Additional links between obesity and brain shrinkage may be even more fundamental. About 46% of Western Europeans and their descendants carry a gene variant called FTO, which is associated with fat mass and obesity. People who carry this gene weigh on average about 2.64 pounds more and have an extra half-inch of waist circumference compared to those who lack the gene variant.42 Recent findings show that carriers of the FTO gene variant have approximately 8% smaller frontal lobe volumes, and 12% smaller occipital (back of the brain) volumes than people who don’t carry this gene variant. These changes were not associated with differences in cholesterol levels or blood pressure, suggesting an independent relationship.

SLEEP DISRUPTIONS
Sleep disruptions and anxiety also contribute to loss of brain volume. Relatively healthy older adults with short sleep duration have significantly smaller brains than those with longer sleep duration. In addition, for every hour of reduced sleep duration, they experience a 0.59% yearly increase in the size of the blood-filled ventricles and a 0.67% decrease in cognitive performance. Similarly, increases in brain shrinkage are associated with decreased quality of sleep as well.
Poor sleep and anxiety, of course, are related, and one study has shown that middle-aged women who have had longstanding psychological distress (based on a standard questionnaire) are at a 51% increased risk of moderate-to-severe atrophy of the temporal lobes.

SMOKING & DRINKING
Smoking has been recognized as a cause of brain shrinkage since at least 1987. More recent studies have confirmed and extended this association, with evidence that any lifetime history of smoking (even if you currently do not smoke) is associated with faster brain shrinkage in multiple brain regions, compared with people who never smoked.
Chronic alcohol consumption has also been associated with brain shrinkage but in a dose-dependent way. While light-to-moderate drinkers have larger total brain volume than nondrinkers, heavy drinkers are 80%more likely than nondrinkers to sustain frontal lobe shrinkage, compared with nondrinkers, and 32% more likely to have enlargement of the ventricles, indicating shrinkage from within. (A heavy drinker is defined as someone who consumes more than about 15 ounces of pure alcohol per week. A standard drink is equal to14.0 grams, or 0.6 ounces, of pure alcohol.)

NATURAL SUPPLEMENTS THAT PROTECT BRAIN VOLUME
Even though the array of factors that can cause brain shrinkage can be daunting, there is good news. Since brain shrinkage results from the same basic processes that cause other symptoms of aging, it’s likely that brain shrinkage is preventable—especially when caught early enough.
That’s why we want to provide you with information on key nutrients that have been shown to powerfully protect the brain. Here are four of the most potent brain-protecting nutrients.

B VITAMINS
B vitamins are essential for supporting normal metabolic function, especially in the regulation of homocysteine51 (and elevated homocysteine, as we have seen, leads to significant brain shrinkage and dementia, especially when B-vitamins are deficient).
Elderly people are now generally advised to maintain optimal B-vitamin status—and for good reason.  Studies show that people with higher folate levels have slower rates of brain atrophy and a lower rate of conversion from mild cognitive impairment to actual dementia, and those who take folate or B12 have lower grades of brain white matter abnormalities.
While each of these B vitamins provides its own unique benefits, several recent studies show why it’s beneficial to supplement with a combination of folate, vitamin B6, and vitamin B12. This was clearly seen in a double-blind, placebo-controlled clinical trial in adults over age 70 who had mild cognitive impairment.
For the study, one group of subjects took folate (800 mcg/day), vitamin B12 (500 mcg/day), and vitamin B6 (20 mg/day), while the other group took a placebo. After two years, supplemented patients’ brains shrank at an annual rate that was 30% lower than those taking the placebo. Supplemented patients whose homocysteine levels were abnormally high at baseline had a 53% slower brain shrinkage rate than unsupplemented patients, showing that supplementing with B vitamins is especially important in people who have high homocysteine levels.
A follow-up study showed that brain areas most susceptible to atrophy in the early development of Alzheimer’s disease are especially well-protected by the same B-vitamin regimen, with supplemented patients experiencing as much as a 7-fold reduction in shrinkage of those regions.57 Another study, using the same doses of B vitamins, found that supplemented patients had 30% lower mean plasma homocysteine levels, and slower rates of cognitive decline on multiple [standardized] tests.

OMEGA-3 FATTY ACIDS
Omega-3 fatty acids comprise a large and important portion of brain cell membranes, where they participate in a wide variety of cellular functions. Indeed, 30 to 50% of the fatty acids in brain cell membranes are long-chain polyunsaturated fatty acids that include the vital omega-3 group. Brain cell membranes are especially rich in DHA, an essential fatty acid derived only from the diet.
Omega-3s have many functions that help protect brain cells. Omega-3 fats are known to enhance the brain’s relaxing functions.61 This protects brain cells from over-excitation, which is a major cause of brain cell damage that occurs with aging. Omega-3s also help preserve brain cell function by increasing the production of anti-inflammatory signaling molecules in the brain. Similarly, omega-3 fats in brain tissue protect cells from damage induced by stress and elevated stress steroids.
The importance of this protection is especially seen when there’s not enough of this vital nutrient. Indeed, abnormal distributions of fatty acids in brain cells are associated with a variety of mental health disorders, particularly major depression and bipolar disorder.
It is not surprising, then, that age-related changes in brain cell omega-3 fat composition raise the risk of brain abnormalities as people age. By contrast, studies show that a higher omega-3 index (which is the sum of the omega-3 fats EPA plus DHA), is correlated with larger brain volume.
Unfortunately, aging is associated with a significant decline in DHA levels in the brain, a drop that is sharply worsened in Alzheimer’s disease and possibly other neurodegenerative disorders.  This highlights the importance of protecting your brain by supplementing with omega-3 fats.

POMEGRANATE
Pomegranates contain very high levels of polyphenols, which are plant-derived molecules with anti-inflammatory and neuroprotective properties.69 Animal studies reveal that supplementing with pomegranate juice slows the development of Alzheimer-like disease, a major cause of brain atrophy.69-71 This protection may arise from the ability of the polyphenols in pomegranate to slow or stop brain cell death.
Human studies demonstrate significant improvements in cognition and memory with consumption of 8 ounces of pomegranate juice daily, and lab studies with human brain cells in culture show that pomegranate polyphenols protect cells against changes that occur in other neurodegenerative diseases.

RESVERATROL
Resveratrol is a major component of red grapes and certain other dark fruits; it has seen widespread use in preventing aging and age-related cardiovascular and neurologic conditions. Studies in a mouse model of chronic fatigue syndrome (which can produce brain shrinkage) show that four weeks of resveratrol therapy increased the animals’ daily physical activity by more than 20%, possibly as a result of reduced brain cell death.75 In addition, the volume of the memory-intensive hippocampus was larger following supplementation.
Researchers are also exploring resveratrol as a potent neuroprotectant against the brain-shrinking effects of obesity and a high-fat diet. In studies of obese animals (obesity is a cause of brain shrinkage), resveratrol protected brain tissue from oxidative damage, a precursor to brain cell death. And in mice fed a high-fat diet, resveratrol similarly protected against oxidative damage to the vital blood-brain barrier and decreased injury to the endothelial cells in the brain.
These findings in animals may explain the results of a compelling human study in 2014, which demonstrated that, in healthy overweight older adults, supplementing with 200 mg/day of resveratrol improved the functional connections between the hippocampus and the frontal areas of the brain.78 Such changes were accompanied by improved memory performance as well as better blood sugar control, again pointing to the complex interactions of metabolism and brain performance.

SUMMARY
Brain shrinkage is a silent threat to our health and longevity. Loss of brain volume means loss of brain cells, which in turn means loss of memory and learning.
There are a myriad of threats to brain volume as we age. Virtually all of the chronic symptoms of aging have been associated with, and to some extent implicated in, brain shrinkage. In addition, lifestyle habits such as a high-fat diet, sedentary behavior, and smoking or excess drinking can further complicate matters.
Fortunately, like other symptoms of aging, brain shrinkage appears to be preventable through a combination of lifestyle changes and sensible supplementation. Start by identifying which aging symptoms most directly affect you, and then focus your supplement regimen on controlling or reversing those factors. With proper care, your brain can maintain its youthful volume and function for years to come.

Saturday, September 1, 2018

ANOTHER 26.7 MILLION PEOPLE HAVE LOST THEIR LIVES TO THE LOSS OF INNOVATION


Dr. Mary Ruwart can be followed at:
Ruwart.com where you can sign up for her newsletter and free library.
Her Facebook page
Her Instagram page.
And her YouTube channel.

[3:27]  RUWART: The FDA, who really controls what you can say about your product, has said that if you make a health claim for a food or a nutrient, it then becomes a drug.  And then it has to go through 12 to 14 years of regulatory hoop-jumping.  
REGULATORY CAPTURE
[3:55] RUWART: Especially, in a highly regulated industry, the industry's survival depends on capturing the goodwill or the funding of the regulatory agency itself.  And that's happened by the Prescription Drug User Fee Act that was passed in 1992.  It started out as a user fee that the drug companies could pay, about $100,000, to speed up the approval process, the FDA's review of 12 to 14 years of data.  And the FDA generally takes a year or two to do that; it was about 2 years in 1992.  But it's morphed into funding most of the FDA's section that approves new drugs.  The numbers that I've seen, say as much as 70% of the salaries of the people who approve drugs now, come from these user fees, which at the last time I saw them were $2 million, which is huge.  So they've captured the . . . getting back to your definition, they've captured the regulators to such an extent that when Vioxx was being debated at the FDA whether they should approve it or not, one of the persons, David Graham, who objected to its approval, was told that the FDA's client was the Pharmaceutical Industry, not the American people, not Congress, but the Pharmaceutical Industry.  So that's a great example of regulatory capture.   [An entire industry!!!]

[5:35] DEIST: Most people tend to think that the FDA keeps us safe from dangerous drugs . . . 

RUWART:  . . . laughter . . . 

DEIST:  Continues . . .  It's not just a safety issue when the FDA tests and bans a certain drug because it causes heart seizures or something like that.  People can see that.  That seems tangible . . . and they can say, well, thank goodness for the FDA for protecting me.  It calls to mind Bastiat's the seen and unseen, what we can't see are all the things that might have been, all the innovative treatments and procedures that might have been had the FDA not been in the way.  

[6:10RUWART:  Yes, but with the Pharmaceutical industry we have studies that actually show that impact to a large degree.  In 1962, the Kefauver-Harris Amendments to the Food and Drug Act were passed.  And this really gave the FDA almost unlimited power over the pharmaceutical industry.  And the time it took to get a drug from the lab bench to the marketplace went from 4 years to 14 years by the 1980s because the FDA didn't want Congress to come down on them if there was a side effect for a drug, and all drugs have side-effects, so they would keep asking for more and more studies.  And because we know roughly how many lives each drug that's on the market today saves, you can actually calculate the number of people who have died waiting for new drugs because of these amendments.  It's about 15 million people through 2009.  And then we also have studies that show loss of innovation and late-stage development.  So for example, after the companies spent maybe 10 years working on a drug about 50% of them are dropped, not because they don't work, not because they aren't safe, but for economic reasons that the manufacturer realizes that they won't recover its costs or make enough profit to make it worthwhile to continue.  If we're only losing only 1/2 of our innovations, and we estimate that maybe 25% are as effective as the drugs we have on the market today, that's another 26.7 million people who've lost their lives to loss of innovation.  And lots of innovation actually gets lost before development even begins.  I had the FDA actually call me up one day and say, "Dr. Ruwart, we understand you have this patent now that you've applied for the treatment of liver disease with prostaglandins, which by the way are a natural substance and every cell in your body makes.  And I said, "Yes, that's true."  And the examiner said "Well, we're very excited at the FDA about this.  A hundred thousand people die every year from liver disease and we can only recommend bed rest.  So we want to let you know that we're here to help you get this drug to market."  But the problem is that when you have a truly new drug, you don't know how many times a day you have to give, you don't know what dose you need to give, and for a long-term disease like liver disease you don't know how long you need to treat.  So you don't know how many people you need in your study, and if you guess wrong on any of this, and you do an effectiveness study, which takes years, and you don't get the statistical significance that the FDA wants, you have to start over.  And Upjohn Management figured out that if we did start out, our patent would be gone and we would never be able to recover costs.  And I'm not a big believer in patents, but when you have this much regulation, there's no hope of recovering your costs unless of course, you have some type of monopoly protection, in this case, bans.  So I suspect that many, many drugs drop out in late-stage are never developed because the company can estimate it's just not going to make them any money.  So there's a lot of innovation that is lost, so my numbers are conservative and if you crank through these numbers probably every one of us has lost 5 years of our lives to these regulations that were passed in 1962.  The good news is that the regulators are losing 5 years, too.  And so is Congress, so maybe we get this changed.  

[9:50DEIST:  But when you talk about a drug taking 15 years to get to market, what you're essentially saying is that small or start-up pharmaceutical companies almost can't exist . . . you have to be big and rich.

[10:00RUWART:  Well, that's right.  What happens is today a lot of small companies start up and they do just the initial studies, of what we call Phase 1 Safety Testing in people, to get to that stage and then hand off their product to one of the big pharma companies that have enough money to take a big hit because it takes about $2 billion to bring a drug to market.  So if at the last moment, you pull the drug or the FDA won't approve it, obviously you lose a lot of money and small companies can't take that hit, but if you hand it off to a big pharmaceutical firm, a big firm who can take a hit, they lose a lot of potential profit.  

Get Dr. Ruwart's book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It, Dr. Mary J. Ruwart, 2018.