NCI Well Connect Mid-Week Brief
August 21, 2019

DID YOU KNOW that  Steve just completed a review study of the latest research on time-restricted feeding (TRF) , a popular intermittent fasting technique?

You can read the entire study here or it is summarized for you below.

TRF is a fasting method where one eats within a finite window of time, usually within a 6 to 8 hour period. For example, you can eat your meals between 10AM and 6PM (8 hours) or 12PM and 6PM (6 hours). The rest of the 16 to 18 hours are fasting. Water is fine.

SUMMARY: The data supports the idea that TRF has a beneficial impact on multiple health outcomes in men. In  order to fully support TRF, however, researchers will need to perform more studies, with larger populations of men and especially women, and for much longer periods of time than what currently exists. It would make sense to pinpoint the ideal number of fasting hours, which is likely to be 16 hours, based upon the majority of research to date. That said, TRF has exciting potential as a technique not just to treat weight issues, but numerous maladies affecting the world's population.

  • Do not try TRF on your own. Please work with a licensed health professional. TRF is contraindicated in those with blood sugar disorders, especially type 1 and type 2 diabetes.
  • Until the TRF research is more substantive, Bonnie wants a small serving of protein eaten every morning (usually around the 12 hour mark).

Any college student should have these on hand. The ones in bold should be taken on a daily basis (if tolerated). The others should be taken as needed.
  • Probiotic (to balance microflora)
  • Magnesium Glycinate (anxiety and stress)
  • Monolaurin (viral preventive)
  • Grapefruit Seed Extract (bacterial preventive)
  • Vitamin D3 1000-5000IU (immune system support)
  • NutriBiotic Throat Spray (soothe sore throat, respiratory issue)
  • Zinc Sulfate Solution (soothe sore throat, respiratory issue)
  • Melatonin 0.5 - 3 mg. (sleep support)
  • Alka Support (sour, upset stomach)

Have a happy, healthy day! Steve and Bonnie
Most New Drugs Have No Evidence of Added Benefit

Steve & Bonnie:  Most new drugs entering the market provide no additional benefit over and above the existing standard of care, and cost Western nations billions, according to studies from British Medical Journal and Annals of Internal Medicine.

In the Annals study, Medicare could have saved close to $17 billion from 2011-2017 by substituting 12 older drugs (racemic precursors) for newer single-enantiomer drugs, and patients could have saved more than $1 billion in out-of-pocket costs.

According to the lead author, "we undertook this study to better understand a clinical situation we were observing all too frequently in clinical practice: patients being prescribed more expensive, branded single-enantiomer drugs when less expensive, generic versions of their racemic precursors are available for use." 

In the BMJ study, investigators found that only 25% of the 216 new drugs entering the German market between 2011 and 2017 were judged to have a considerable, or major, added benefit. For 16% of these new agents, this additional benefit was either minor or could not be quantified. In addition, for 58% of these medications there was no proof of added benefit versus standard of care in the approved patient population. The field of psychiatry/neurology fared the worst with just one of 18 new drugs showing added benefit. New drugs for diabetes also performed badly with only four out of 24 showing extra value.

The investigators acknowledge the argument that drugs can be approved without showing "added benefit" data to allow speedy access to new products, with the promise of future comparative studies. However, they note, such promises are often never fulfilled.

"A critical and well known problem with post-marketing studies is they often do not happen.... Globally, regulators do little to sanction non-compliant companies," they write.

The investigators also suggest that health policy makers need to take a more proactive approach in the drug development process.

"Rather than waiting for drug companies to decide what to develop, they could define the health system's needs and implement measures to ensure the development of the treatments required," they write, adding that this could include needs-oriented public-private partnerships and not-for-profit drug development.

Sobering stuff. We are shocked that the editors published these studies given that both are rewarded handsomely from Big Pharma advertising revenue.
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Public Health Alert Update

This article is reserved for NCI Well Connect Members.


Steve & Bonnie: Some exciting, some scary, but a must read for sure...

ADHD Meds Ritalin and Concerta
A study from Radiology states that Methylphenidate (MPH), sold under trade names including Ritalin and Concerta,  appears to affect the development of the brain's signal-carrying white matter in children with ADHD, while the same effects were not found in adults using MPH for ADHD.  "What our data already underscore is that the use of ADHD medications in children must be carefully considered until more is known about the long-term consequences of prescribing methylphenidate at a young age," the authors said.

Androgen Deprivation Therapy
Among elderly patients with prostate cancer, androgen deprivation therapy exposure was associated with subsequent diagnosis of Alzheimer disease or dementia over a follow-up period of at least 10 years, according to a new JAMA Network Open study.

In addition, a study in Bone showed not only an accelerated decline in areal bone mineral density, the treatment also affects bone in other ways, such as reduced bone strength at bone sites of the forearm and lower leg, with the honeycomb-like trabecular bone, rather than the dense cortical bone, mostly affected by this treatment.

A new report from Journal of Medical Case Reports found a suggestive causal link between use of ciprofloxacin ("Cipro") and hypoglycemia in patients without diabetes. Cipro is an antibiotic from the fluoroquinolone class, which contains myriad side effects, some devastating. For example, in a recent JAMA Neurology study, oral fluoroquinolone therapy was associated with an increased risk of incident peripheral neuropathy.

In a new study from Current Opinion in Nephrology and Hypertension, evidence suggests a possible, causal role of antibiotics in the development of kidney stones. A possible explanation for this finding includes alterations in the microbiome, especially effects on oxalate-degrading bacteria. Ample reasons to encourage antibiotic stewardship already exist, but the possible role of antibiotic exposure in contributing to the increasing prevalence of kidney stones in children and adults is another rationale.

Women in middle or late life who use antibiotics on a long-term basis have a higher risk for cardiovascular disease (CVD) events, new research in European Heart Journal suggests. Women 60 years or older who took antibiotics for 2 months or more had the greatest risk for CVD, but long-term use of antibiotics was also associated with increased cardiovascular risk if taken by women at midlife (40-59 years).

A JAMA Internal Medicine study confirms that exposure to several types of strong anticholinergic drugs is associated with an increased risk of dementia. These findings highlight the importance of reducing exposure to anticholinergic drugs in middle-aged and older people.

Common antidepressants interact with the opioid pain medication tramadol to make it less effective for pain relief, according to a study from Pharmacotherapy . These findings have important implications for the opioid epidemic, suggesting that some patients suspected of drug-seeking may in fact be under-medicated and just are seeking more effective pain relief. They also could help explain why some people exceed the prescribed dose of tramadol, increasing their risk of addiction.

More evidence is linking use of antipsychotics to an increased mortality risk in patients with dementia. In a study of patients with dementia, those who received an antipsychotic drug had a 35% increased risk of mortality compared with their peers who did not receive this type of medication. The research was presented recently at the Congress of the European Academy of Neurology 2019.

According to a new study in JAMA Neurology, among people without symptomatic cardiovascular disease, use of low-dose aspirin was associated with an overall increased risk of intracranial hemorrhage, and heightened risk of intracerebral hemorrhage for those of Asian race/ethnicity or any ethnicity with a low body mass index.

In a JAMA Psychiatry study of 442,066 pregnancies, an association between benzodiazepine exposure during early pregnancy and risk of spontaneous abortion was found for short and long-acting benzodiazepines and all specific benzodiazepine agents. Insomnia, anxiety, and mood disorders are prevalent during pregnancy, so you should carefully evaluate the risk/benefit ratio of taking benzodiazepines in early pregnancy since alternative nonpharmacologic treatments exist.

People who have recently used cannabis may be more likely to experience memory deficits or difficulties with cognitive function than those who don't use the drug, a recent study in Journal of Psychiatry and Neuroscience suggests. In the study, people who tested positive for THC scored worse on tests of so-called episodic memory and of mental processing speed. This is yet another example why one needs to screen for their genetic compatibility to cannabis with THC.

A new study in the Journal of the American Academy of Child and Adolescent Psychiatry reports that alterations in cognitive control, an ensemble of processes by which the mind governs, regulates and guides behaviors, impulses, and decision-making based on goals are directly affected by marijuana use in young persons. The researchers found greater and more persistent alterations in individuals who initiated cannabis use earlier, while the brain is still developing.

Dietary Supplements
Consumption of dietary supplements sold for weight loss, muscle building, and energy was associated with increased risk for severe medical events in children and young adults compared to consumption of vitamins, according to new research in Journal of Adolescent Health. The study found that, compared with vitamins, these types of supplements were linked to nearly three times as many severe medical outcomes in young people. These supplements have, and will continue to give the industry a bad name.

Fecal Transplants 
The FDA is alerting healthcare providers and patients that fecal microbiota for transplant (FMT) may transmit multidrug-resistant organisms, leading to serious or life-threatening infections. The FDA said two immunocompromised adults who received FMT developed invasive bacterial infections from the same fecal donor. The donor stool was not tested for ESBL-producing gram-negative organisms prior to use, which is customary protocol.

Hepatitis B
The U.S. Preventive Services Task Force recently gave an 'A' level recommendation to screening women for hepatitis B in their first trimester of pregnancy, according to a recent report in JAMA.

The FDA approved a new source of iron, oral ferric maltol (Accrufer), to treat iron deficiency in adults. It is 30 mg. per dose and contains the following horrific inactive ingredients: colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate and sodium lauryl sulfate as inactive ingredients. In addition, the capsule shell contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No.6, gelatin and titanium dioxide. The ink used for printing the marking contains ammonium hydroxide, ethanol, iron oxide black and propylene glycol. PLEASE AVOID!

This is not the first study showing the negative effects of metformin. In Journal of Clinical Endocrinology & Metabolism, data from older adults without dementia were evaluated to investigate the impact of hyperglycemia and metformin use on relevant vitamin B biomarkers and cognitive outcomes. Metformin use was associated with a significantly higher risk of vitamin B12 and vitamin B6 deficiency. Even with hyperglycemia, metformin use was associated with a significantly increased risk of cognitive dysfunction. Deficiencies of folate-related B-vitamins can arise with metformin treatment and are independently linked with cognitive dysfunction.

TNFa Drugs
Anti-TNFa drugs used for things like lupus and rheumatoid arthritis can lead to Crohn's and Inflammatory Bowel Disease (IBD). It may seem confusing because different anti-TNFa agents are used for Crohn's and IBD. Simply, in patients treated for anything other than Crohn's and IBD, TNFa agents are twice as likely to develop Crohn's disease (CD) or ulcerative colitis (UC). Anti-TNFa agents are commonly treated for rheumatologic conditions, but researchers from the Alimentary Pharmacology and Therapeutics study are cautioning against this.

Reflux in Young Children
Acid-suppression therapy early in life is associated with an increased risk of fracture in childhood. The findings, together with other negative research about proton-pump inhibitor (PPI) use in young children, suggest that providers should be much more judicious in their prescribing of these medications to very young children.

The use of PPIs and histamine H2-receptor antagonists (H2RAs) in infants quadrupled from 1999 to 2003 and then doubled from 2004 to 2008, researchers note in Pediatrics .

While acid-suppression medication is sometimes necessary in infants with GERD, these medications are often used to treat newborn reflux and crying, which are normal newborn behaviors .
We appreciate your continued patronage and support.

Have a happy, healthy day,
Bonnie, Steve, Carolyn, Lilo, Elizabeth, Sharron, and Lori
(847) 498 3422

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