Shorts

Jule Klotter

More Censorship

Editors of Elsevier’s Pharmacological Research withdrew a 2018 study, “Cognition and behavior in sheep repetitively inoculated with aluminum adjuvant-containing vaccines or aluminum adjuvant only,” from publication. A letter from the publisher to senior author Lluís Luján asserted that the paper was not retracted, “’which implies wrongdoing,’” according to journalist Celeste McGovern. The study reported distinct behavioral changes in sheep who received aluminum-containing vaccines or aluminum adjuvant alone, compared to those receiving a saline placebo.

The withdrawal occurred after behind-the-scenes complaints about methodology. Usually, questions and comments about a study are posted in a letter to the editor and the study’s authors publicly respond. Dr. Luján responded to the complaints, which he deemed ‘misleading’ and ‘spurious’. The journal’s statistical editor reviewed the study’s raw data and did not recommend withdrawing the paper. In email correspondence from Elsevier, “’concerns from the readership’ morphed into ‘a signed note of concern from a reader,’” writes McGovern. The identity of this reader was never revealed. Dr. Luján refused to withdraw the study himself, so the editors did it.

This 2018 study is one in a series of studies investigating a disturbing and mysterious outbreak that developed in Spanish sheep in 2009, after widespread vaccination for bluetongue, a non-contagious, viral illnesses transmitted by midges (tiny flies). The animals became unusually nervous and disoriented. Some began biting wool off others in the flock and eating it. Some were lethargic. Others had seizures and died. With winter cold, animals lost weight, looking emaciated, and developed muscle tremors. Spanish veterinarians and researchers investigated all possible sources for the malady, searching for pathogens and environmental toxins in food and water. Some farmers reported that their sheep developed these odd symptoms after bluetongue vaccination. Dr. Luján could not believe it at first: “’But it was just too much coincidence.’” In medical literature, he found studies on autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and was struck by the similarity to the sheep’s malady.

In 2013, Luján and his team published a paper describing post mortem findings from 64 sheep with “ovine ASIA.” The animal bodies displayed thickened nerves on their backs, abdomens, and legs. Evidence of brain inflammation and ‘severe neuron necrosis’ was found. Aluminum (Al) was present in the nerve tissue. The researchers were able to induce the disease with aluminum-containing vaccines.

In 2018, Luján’s team published a placebo-controlled experiment with 84 male neutered lambs that were divided into three groups; one group was given commercial aluminum-containing vaccines, the second got an equivalent amount of aluminum adjuvant, and the third got a saline placebo. The animals received 19 subcutaneous injections within 15 months. Their Veterinary Pathology article reported that “[a]ll of the vaccine and 92.3% of the adjuvant-only lambs presented injection-site granulomas….” The number of granulomas was higher in the vaccine group. Most troubling was the high aluminum content in the lymph nodes of the vaccine group: vaccine group (median 82.65 µg/g), adjuvant-only (median 2.53 µg/g), control (median 0.96 µg/g). Scanning transmission electron microscopy revealed aluminum (Al) in the macrophages belonging to animals in both treatment groups but not the saline control group: “In these two groups, Al-based adjuvants induce persistent, sterile, subcutaneous granulomas with macrophage-driven translocation of Al to regional lymph nodes.”

In another 2018 study, published in Frontiers in Immunology, Spanish researchers used RNA sequencing to investigate aluminum hydroxide’s effect on the immune response. They compared vaccinated sheep to sheep injected with this widely used aluminum adjuvant. They found the adjuvant, in itself, increased expression of inflammatory cytokines, NF-Kβ family genes, and apoptotic genes. In addition, aluminum affects DNA repair. The authors state: “…these experiments demonstrate that aluminum containing adjuvants are not simply delivery vehicles for antigens but can also induce endogenous danger signals that can stimulate and modulate the immune system.”

The withdrawn Pharmacological Research study focused on changed behavior caused by the aluminum-containing vaccines. The researchers assigned 21 unvaccinated, neutered Rasa Aragonesa lambs (known to be a gregarious breed) to one of three groups. The food, water, and pens for each group were identical, and all lambs received 16 injections in 12 months. Group A (control) received phosphate-buffered saline; Group B received aluminum adjuvant (equivalent to vaccine content; 70.861 mg), and Group C received commercial aluminum-containing vaccines. The animals were tested in summer and winter for cognitive changes (maze test, open field test, and novel object test). During the testing period, a video camera recorded behavior in the pens for 12 hours/day on seven consecutive days. The recordings were later analyzed by a blinded researcher.

The cognitive tests showed no significant differences between the groups. Behaviors, however, were significantly different. Lambs in groups B and C spent more time standing than the placebo group. During the winter test period, lambs in Groups B and C showed more aggressive interactions, fewer affiliations, and stereotypies—that is, repetitive movements (such as rubbing against the wood pen) for no apparent reason. In contrast, aggressive behavior and stereotypies were consistently low in Group A in both summer and winter. In addition to behavior changes, cortisol levels during winter were significantly higher in the two treatment groups compared to the control. Unlike groups B and C, the placebo group’s median cortisol level had significantly decreased from its summer level. The researchers could not say whether the more pronounced behavior changes observed in winter were due to the cold weather, the greater number of inoculations that had occurred by that point, or both.

The authors wrote: “In our opinion, all these behavioral changes exhibited by the Vaccine and Adjuvant-only lambs in our study are of outmost importance, as they are the first scientific explanation of some of the previously observed behavioral changes in flocks….Indeed, these changes can be undoubtedly detected by veterinarians and farmers in field conditions but they have never been scientifically linked to vaccination and/or Al inoculations.”

Dr. Luján told McGovern that aluminum in animal vaccines has been known to cause other problems, such as cancer in cats. When veterinary researchers removed Al from cat vaccines, the incidence of cancer at injection sites “all but disappeared.” Clearly, it is possible to make vaccines safer. Unfortunately, Dr. Luján and other veterinarians have found that oversight and public health agencies do not want to hear about the problems with aluminum-containing vaccines: “One colleague told him that every time he reported ASIA symptoms to oversight agencies, his complaints were ignored.”

Elsevier’s withdrawal of this study is not the only example of attempts to censor information about aluminum toxicity. Aluminum expert and toxicologist Christopher Exley, a professor of bioinorganic chemistry (Keele University, UK), was one of the authors of the Veterinary Pathology article. Since finding extremely high levels of aluminum in the brains of people with diagnosed autism, funding from government sources has disappeared; he now relies on private sponsors. He turned to GoFundMe for donations. In keeping with the clampdown on vaccine debate, GoFundMe deleted his account in April 2019, and returned the money to his donors. For those interested, it is still possible to support research on aluminum via a link on Keele University’s website.

Asin J, et al. Cognition and behavior in sheep repetivitely inoculated with aluminum adjuvant-containing vaccines or aluminum adjuvant only. Pharmacological Research. 2018. Available at www.iisaragon.es with supplemental material.

Asin J, et al. Granulomas Following Subcutaneous Injection with Aluminum Adjuvant-Containing Products in Sheep. Veterinary Pathology. 2018;1:11.

McGovern C. Anatomy of a science study censorship. March 20, 2019.

Varela-Martinez E, et al. Molecular Signature of Aluminum Hydroxide Adjuvant in Ovine PBMCs by Integrated mRNA and microRNA Transcriptome Sequencing. Frontiers in Immunology. October 23, 2018.

Medium-Chain Fatty Acids Repel Insects

Medium-chain fatty acids (C8:0 to C12:0) found in coconut oil repel biting flies, bedbugs, ticks, and mosquitoes, according to a 2018 report by a team of entomologists and US Department of Agriculture scientists. After testing the various fatty acids in whole coconut oil, they found that only caprylic acid (C8:0), which comprised about 6.85% of their tested coconut oil, capric acid (C10:0), comprising about 7.33%, and lauric acid (C10:0), comprising about 52.68%, had a noticeable repellent effect. Coconut oil, itself, was not effective in repelling biting flies. Much of this study focused on finding a natural repellent for biting flies that afflict US livestock, causing over two billion dollars in losses. The researchers say, “Coconut oil’s lack of repellency suggests that the large bulky nature of the triglyceride structure may play a role in determining the repellency properties….” The effectiveness and longevity of these compounds were as good as or better than DEET’s. The pesticide DEET is considered the gold standard insect repellent but has been linked to multiple health problems.

In laboratory tests, the researchers found that a compound of these three fatty acids repelled stable flies, horn flies, and bed bugs more effectively than DEET. Moreover, the fatty acids had over one week of activity while DEET’s effect began to decline by day 3. Coconut fatty acids and DEET, at concentrations of 0.05 mg/cm², showed basically the same ability to repel lone star ticks; and, at concentrations of >0.4 mg/cm², the coconut fatty acids had the same repellent activity against yellow fever mosquitoes as DEET.

Researchers have investigated other natural options for repelling biting insects, including essential oils such as catnip oil, citronella, and palmarosa; but their effectiveness wanes within hours, and some have toxicities of their own. This investigation of coconut fatty acids suggests that a non-toxic, effective insect repellent is possible for animals and humans alike.

Zhu JJ, et al. Better than DEET Repellent Compounds Derived from Coconut Oil. Scientific Reports. 2018;8:14053.

Proton-Pump Inhibitors and Kidney Damage

Proton pump inhibitors (PPIs), such as Nexium, Prevacid, and Prilosec, have largely supplanted histamine H2-receptor antagonists (H2RAs; e.g., Tagamet, Pepcid, Zantac) as the preferred treatment for gastric ulcers, esophagitis, and acid-related disorders. Initially recommended for short-term use, PPIs are often used long-term; and their perceived safety has led to over-the-counter availability. Concerns have arisen about possible kidney damage with long-term PPI use.

A 2019 study, led by Tigran Makunts, found evidence of an association between PPI use and kidney damage. For this study, the researchers used data from the FDA Adverse Event Reporting System (FAERS), a post-marketing surveillance system that collects reports of possible adverse drug effects that are voluntarily submitted by healthcare practitioners, pharmacists, patients, and lawyers. Makunts et al sifted through over 10.3 adverse effect reports, submitted from January 2004 to March 2018, to isolate 42,537 reports in which PPIs were used as monotherapy and 8,309 reports in which only H2RAs were used. They used the data to perform an odds ratio analysis, comparing adverse event frequency in the two types of medications. They also looked at frequency of adverse events for each of the five PPIs that appeared in adverse effects reports: omeprazole (Prilosec; n=7,749), esomeprazole (Nexium; n=27,053), pantoprazole (Pantoloc; n=3,651), lansoprazole (Prevacid; n=3,360), and rabeprazole (Aciphex; n=724).

Compared to patients using only H2RAs, those on PPI monotherapy were more likely to report chronic kidney disease (OR 28.4, 95% CI [12.7, 63.5]), acute kidney injury (4.2 [2.8, 6.3]), end-stage renal disease (35.5 [5.0, 250.0]), renal impairment of unspecified type (8.0 [5.0, 13.0]), and kidney stones (2.8 [1.3, 6]): “The composite renal ADR frequency was 5.6% of the total PPI ‘monotherapy’ ADRs reports and 0.7% for H2RA ‘monotherapy’ reports (8.6 [6.6, 11]).”

In addition to kidney damage, the researchers also found an increase in electrolyte abnormalities among PPI users. Patients on PPI monotherapy were more likely to report hypomagnesemia (OR 78.5 [11, 560]), hypocalcemia (25.5 [6.4, 100]), hypokalemia (6.3 [1.6, 15]), and hyponatremia (2.2 [1.1, 4.6]). The authors note that hypomagnesemia (low magnesium blood levels) is listed as a rare side effect on the package inserts; but it may be subject to detection bias. Unlike calcium, potassium, and sodium, magnesium levels are not routinely measured. Makunts et al say, “It may be prudent to monitor magnesium levels in patients with ongoing PPI therapy and other risk factors for hypomagnesemia.”

The lack of comprehensive medical records is a stated limitation of this study, and the reports can only indicate an association—not causality. The authors note that FAERS/AERS reporting “does not represent the population incidence” because reporting is voluntary, which suggests that many adverse events may not be reported. People with compromised kidney function might consider using an H2RA, if possible. At the very least, renal function and electrolytes need to be monitored if PPI use extends beyond the authors’ recommended four-to-eight weeks.

Doctors Deny That PPIs Can Cause Kidney Damage. Peoples Pharmacy. April 8, 2019.

Makunts T, et al. Analysis of postmarketing safety data for proton-pump inhibitors reveals increased propensity for renal injury, electrolyte abnormalities, and nephrolithiasis. Scientific Reports. 2019;9:2282.

Benefits of a Short Forest Bathing Program

Taiwan researchers tested the effects of a two-hour forest bathing program on 128 middle-aged and elderly people, age 45-86 years (mean 60.0 ± 7.44), 46.1% of whom (n=59) reported chronic illnesses such as diabetes, hypertension, and heart disease. The experience—in groups of 12—took place in a valley, planted with Japanese cedar and giant timber bamboo 40 to 90 years ago and surrounded on three sides by mountains. While walking 2.5 km (about 1½ miles) through the forest, participants were guided to use their four senses to see the scenery, listen to birds and running streams, smell the wood, and feel the surfaces of leaves and trees. Pulse rate, systolic and diastolic blood pressure, and heart rate variability (to indicate sympathetic-parasympathetic nervous activity) as well as psychological measures were taken before and after participation in the program.

Participants’ pulse rate and blood pressure (systolic and diastolic) decreased significantly after the program, “which indicated physiological benefits from stress recovery.” There was no statistically significant change in autonomic nervous activity. In addition, all negative mood scores (“tension-anxiety,” “anger-hostility,” “fatigue-inertia,” “depression-dejection,” and “confusion-bewilderment”) significantly decreased, and the positive measure for “vigor-activity” increased. Chia-Pin Yu et al say, “Although some studies have suggested that longer forest bathing programs have a more beneficial effect, the present study clearly demonstrated that among middle-aged and elderly individuals, the short forest bathing program was associated with stress recovery.”

The authors state that the lack of possibly confounding variables (e.g., socio-economic status, lifestyle habits, etc) is a limitation of the study. I also wonder how this type of sensory exercise compares to a simple hike in the woods or walk around a city park. Or is mindful attention to sensory input a key part of the benefits?

Yu C-P, et al. Effects of Short Forest Bathing Program on autonomic Nervous System Activity and Mood States in Middle-Aged and Elderly Individuals. Int J Environ Res and Public Health. 2017;14:897.