Archive for the ‘research’ Category

Lyme Vaccine to be Tested on Humans

http://www.thevaccinereaction.org/2017/01/fda-gives-green-light-to-test-lyme-disease-vaccine-on-humans/  by Patrice La Vigne and Barbara Loe FisherPublished January 25, 2017

Reprinted here:

Valneva’s preclinical study on mice reveal protection against Lyme disease transmitted by ticks among the majority of Borrelia bacteria strains.
Clinical trials for a new Lyme disease vaccine will be conducted in the U.S. and Belgium after the U.S. Food and Drug Administration (FDA) and European Union’s Clinical Trial Application gave Biotech firm Valneva of France clearance to begin Phase I testing.1

Valneva is developing VLA15, a hexavalent, protein subunit-based vaccine for protection against Lyme’s disease, a tick-transmitted bacterial infection characterized by fever, headache, fatigue and skin rash that, if left untreated, can spread to the joints, heart and nervous system and cause severe, chronic health problems.2 The vaccine targets the outer surface protein A (OspA), one of the most dominant antigens expressed by the Borrelia bacteria transmitted by a tick.1

The serotypes expressed by the U.S. species of the Borrelia bacteria differ from the European version of the bacteria. In fact, there are six types of the proteins. Valneva’s vaccine aims to target all different strains of OspA and teach the body’s immune system to recognize the bacteria and launch an attack.3

First Lyme Vaccine Withdrawn After Injury Claims
This is not the first time a company has pursued a Lyme disease vaccine candidate, although there are no vaccines currently on the market.

In 1998, the FDA approved LYMErix, manufactured by SmithKline Beecham (now GlaxoSmithKline) of the United Kingdom. Patients received three doses of the vaccine, which was manufactured using a recombinant Borellia burgdorferi outer surface protein (OspPA). The company claimed an effectiveness rate of 80 percent.

However, almost immediately after the vaccine was licensed and distributed, there were complaints that LYMErix vaccine was causing Lyme disease symptoms and in some cases was causing permanently disabling brain and immune system damage, including treatment resistant autoimmune arthritis.The biological mechanism hypothesis was that the outer surface protein A (OspA), which was the antigenic component of the LYMErix vaccine, induced autoimmunity in genetically susceptible individuals, including high levels of autoantibody to OspA in their synovial fluid. On Jan. 31, 2001, the FDA advisory committee held a public meeting to review the evidence for the vaccine’s safety and public comments were made by physicians, research scientists, individuals alleging LYMErix injury and attorneys.4

GSK voluntarily withdrew LYMErix vaccine from the market in 2002 citing uncertainty about risk of the disease and low public demand. However, they stopped producing the vaccine soon after a class action lawsuit involving hundreds of patients, who claimed they were injured by LYMErix, was settled out of court. GSK denied the vaccine caused harm and the vaccine industry and public health officials placed blame on the media for publicizing reports of vaccine reactions.

Other Lyme Vaccines Failed to Materialize
Pasteur Merieux Connaught of France moved its vaccine through to Phase III testing with positive results, however the company never sought licensure, citing a small market size.5 Baxter of Deerfield, IL was also recently developing a potential vaccine candidate against Lyme, but similarly abandoned the initiative.6

Seeing an experimental vaccine through to Phase III testing can cost a company more than $1 billion. About 86 percent of experimental drugs do not clear Phase I and II studies.

Valneva Vaccine Targets Six OspA Serotypes
Valneva’s preclinical study on mice reveal protection against Lyme disease transmitted by ticks among the majority of Borrelia bacteria strains.7

Phase I human trials at a U.S. site and a Belgium site will enroll 180 patients aged 18 to 40 years. The single-blind, partially randomized, dose escalation study will focus on evaluating VLA15’s safety and tolerability among different dose and formulation groups and time points. Researchers will measure immunogenicity by observing IgG antibodies against six OspA serotypes.

Call for Extensive Safety Testing of New Lyme Vaccine
According to the U.S. Centers for Disease Control and Prevention, approximately 300,000 Americans and 85,000 Europeans develop Lyme disease annually. The CDC states that Lyme disease is one of the fastest growing vector-borne infections in the U.S. and Congress made development of a new Lyme disease vaccine a funding priority in the 21st Century Cures Act passed at the end of 2016.8 9

Two researchers warned several years ago that new Lyme disease vaccines using the outer surface protein (OspA) must be thoroughly tested for safety. They said, “Any new Lyme vaccine will need extensive safety testing, more transparency about side-effects, and improved patient communication to allay patient concerns about safety. Let’s hope that history does not repeat itself because Lyme vaccine manufacturers, regulators, and promoters once again underestimate or ignore justified patient concerns about Lyme vaccination risks.”10

Please read Dr. Stricker’s comment about the vaccine:

Safety, immunogenicity, and efficacy of Borrelia burgdorferi outer surface protein A (OspA) vaccine: A meta-analysis.

Zhao H.J Infect Dev Ctries. 2017.1 comment

Raphael Stricker2017 Feb 08 1:33 p.m.edited

Another Lyme OspA Vaccine Whitewash

The meta-analysis by Zhao and colleagues comes to the conclusion that “the OspA vaccine against Lyme disease is safe and its immunogenicity and efficacy have been verified.” The authors arrive at this sunny conclusion by excluding 99.6% of published articles that demonstrate potential problems with the OspA vaccine. Furthermore, the authors ignore peer-reviewed studies, FDA regulatory meetings and legal proceedings that point to major problems with OspA vaccine safety (1-3). This whitewash bodes ill for future Lyme vaccine candidates because it fosters disregard for vaccine safety among Lyme vaccine manufacturers and mistrust among potential Lyme vaccinees.

References 1. Stricker RB (2008) Lymerix® risks revisited. Microbe 3: 1–2. 2. Marks DH (2011) Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med. 23: 89–96. 3. Stricker RB, Johnson L (2014) Lyme disease vaccination: safety first. Lancet Infect Dis. 14(1):12.

 

For more on Lyme Vaccines:  https://madisonarealymesupportgroup.com/2016/08/04/vaccine-injuries-and-the-lyme-connection/

 

Category:

Activism, Lyme, Lyme Vaccine, research, vaccines

NTZ – Game Changer for Lyme Patients?

https://www.linkedin.com/pulse/nitazoxanide-known-killer-parasites-borrelia-cysts-booster-ozimek?trk=v feed&lipi=urn%3Ali%3Apage%3Ap_flagship3_feed%3BjOKiznIW%2BSs5upN50KaGRg%3D%3D

Is nitazoxanide (NTZ)- a real game changer for Lyme patients?
Written by:  Wojciech Piotr Ozimek, independent lecturer and researcher specialized in parasitic and vector-borne diseases.  Used with permission.

Nitazoxanide, a thiazolide compound, and its desacetyl derivative, tizoxanide, have antimicrobial properties against protozoa, cestodes, nematodes, trematodes, bacteria and viruses.

A retrospective review of charts of patients treated with nitazoxanide for infections caused by giardia lamblia, cryptosporidium parvum, blastocystis hominis, entamoeba histolytica, cyclospora, isospora and babesia caused infections demonstrated it’s high efficacy.

Unfortunately most of the studies showed that nitazoxanide is rather ineffective for the treatment of trichomoniasis.

Because the treatment of Helicobacter pylori infection may be jeopardized by metronidazole resistance, nitazoxanide and tizoxanide were tested in vitro and in vivo studies. Conclusions? It may be used as a single agent in the treatment of Helicobacter pylori and other Campylobacter sp. caused infections. It is also effective against Clostridium difficile caused infections.

There has been a study that claims there is some limited evidence for efficacy for SIBO (small intestinal bacterial overgrowth) in the context of an open label study, but no systematic review and all claims should be taken lightly.

Development of resistance to the two main classes of drugs used to treat intestinal nematode infections of humans has been reported. We need new and more effective drugs and ways to improve the efficacy of the old drugs. And again the promising alternative drug is nitazoxanide (NTZ). NTZ shown to have therapeutic activity against nematode (ascaris), cestode (taenia, hymenolepsis) and trematode (fasciola) infections. In addition NTZ combines synergistically with other classes of anthelmintic drugs, i.e. albendazole and pyrantel, making it a good candidate for further studies on its use in drug combination therapy of parasitic infections.

Lateef et al.. conducted a study in India that evaluated the effectiveness of nitazoxanide in the treatment of beef tapeworm (Taenia saginata) infection. They concluded that nitazoxanide is a well-tolerated drug for the treatment of niclosamide- and praziquantel-resistant beef tapeworm (Taenia saginata) infection.

It is also considered to be a “cyst busting” drug by some researchers, so can theoretically impact Borrelia, too. For these reasons, it is one of my favorite drugs, and in my opinion it should have a broader application for Lyme disease patients.

As if the above-mentioned benefits of nitazoxanide weren’t enough for some skeptics, the drug also impacts biofilm formation. This was shown by research published in Oxford’s Journal of Antimicrobial Chemotherapy, in a study entitled, “Nitazoxanide inhibits biofilm formation by Staphylococcus epidermidis by blocking accumulation on surfaces.” Several other studies also demonstrate nitazoxanide’s inhibition of biofilm forming.

And lastly, nitazoxanide has even been shown to inhibit numerous viruses, including hepatitis B and C viruses, rotavirus and influenza A virus (in vitro).

To summarize, nitazoxanide can be used to kill protozoa, cestodes, nematodes, trematodes, bacteriae (incl. cysts & biofilm forms) and viruses.

It’s no wonder that Lyme patients, who are often afflicted with many of mentioned above infections, can feel so much better as a result of using nitazoxanide.

Nitazoxanide should be one of the most multi-talented and broadly applicable drugs available to Lyme sufferers, and I consider it to be one of the most important medicines presented in the last years.

Nitazoxanide is an effective, inexpensive, and generally safe and well tolerated medicine. In the clinical trials no serious adverse events were reported. Adverse events occur in less than 1% of the patients but physician monitoring is still advisable.

Nitazoxanide is sold under the brand names Nizonide, Nitaxide, Nitax, Zox, Netazox, Niazid, Toza, Daxon, Dexidex, Kidonax, Mitafar, Pacovanton, Paramix, Alinia, Adonid, NT-TOX, Nitamax,and Annita.

 

Category:

C-diff, Lyme, research, Treatment, Viruses

Truth on Mammograms

Lazris & Rifkin’s Risk-Benefit Characterization Theater

Mammograms are said to cut the risk of dying from breast cancer by as much as 20 percent, which sounds like an invincible argument for regular screening.

Two Maryland researchers want people to question that kind of thinking. They want patients to reexamine the usefulness of cancer exams, cholesterol tests, osteoporosis pills, MRI scans and many other routinely prescribed procedures and medicines.

http://articles.mercola.com/sites/articles/archive/2017/01/25/harmful-ineffective-mammograms.aspxutm_source=dnl&utm_medium=email&utm_content=art1&utm_campaign=20170125Z1&et_cid=DM131782&et_rid=1858150143

Dr. Mercola writes that the Huffington Post stated in a recent article that fewer women are going to be screened for breast cancer with mammograms, if Obamacare is repealed. He asks if that’s a bad thing since “studies have repeatedly negated the idea that mammograms lower death rates, noting more women are harmed in the process than are actually saved.”

Mercola states that if you feel an actual lump in your breast a mammogram may be warranted but to consider other non-ionizing alternatives such as ultrasounds as they are considered superior – especially for dense-breasted women who are at a higher risk for a false negative mammogram.

http://www.naturalnews.com/2017-02-15-thermography-uncovering-health-issues-safely.html  A safer alternative, thermal imaging or Thermography, can be performed in about 15 minutes and is safe, non-invasive, painless, and accurate. Unlike mammograms, which can actually increase the risk of breast cancer by bombarding patients with high levels of radiation, thermography emits no radiation.   The technique can also indicate the threat or presence of gum disease, TMJ, dental abscesses, digestive disorders, fibromyalgia, arthritis, heart disease, musculoskeletal injury, and vascular and neurological dysfunction.

 http://health.costhelper.com/breast-thermogram.html   Costs for Thermography are from $175-$250, while mammography costs range wildly from $0-$2,786.95! http://clearhealthcosts.com/blog/2013/05/how-much-does-a-mammogram-cost-prices-payments-vary-widely-our-survey-with-wnyc-finds/

Beyond the initial costs of mammograms are “hidden costs,” which include more testing and over treatment.  http://www.npr.org/sections/health-shots/2015/04/13/398818949/the-hidden-cost-of-mammograms-more-testing-and-overtreatment

 

 

Category:

Activism, research

NASEM Report on Cannabis

http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=24625

Jan. 12, 2017
FOR IMMEDIATE RELEASE

Nearly 100 Conclusions on the Health Effects of Marijuana and Cannabis-Derived Products Presented in New Report; One of the Most Comprehensive Studies of Recent Research on Health Effects of Recreational and Therapeutic Use of Cannabis and Cannabis-Derived Products

WASHINGTON – A new report from the National Academies of Sciences, Engineering, and Medicine offers a rigorous review of scientific research published since 1999 about what is known about the health impacts of cannabis and cannabis-derived products – such as marijuana and active chemical compounds known as cannabinoids – ranging from their therapeutic effects to their risks for causing certain cancers, diseases, mental health disorders, and injuries. The committee that carried out the study and wrote the report considered more than 10,000 scientific abstracts to reach its nearly 100 conclusions. The committee also proposed ways to expand and improve the quality of cannabis research efforts, enhance data collection efforts to support the advancement of research, and address the current barriers to cannabis research.

“For years the landscape of marijuana use has been rapidly shifting as more and more states are legalizing cannabis for the treatment of medical conditions and recreational use,” said Marie McCormick, chair of the committee; the Sumner and Esther Feldberg Professor of Maternal and Child Health, department of social and behavioral sciences, Harvard T.H. Chan School of Public Health; and professor of pediatrics, Harvard Medical School, Cambridge, Mass. “This growing acceptance, accessibility, and use of cannabis and its derivatives have raised important public health concerns. Moreover, the lack of any aggregated knowledge of cannabis-related health effects has led to uncertainty about what, if any, are the harms or benefits from its use. We conducted an in-depth and broad review of the most recent research to establish firmly what the science says and to highlight areas that still need further examination. As laws and policies continue to change, research must also.”

Currently, cannabis is the most popular illicit drug in the United States, in terms of past-month users. Based on a recent nationwide survey, 22.2 million Americans ages 12 and older reported using cannabis in the past 30 days. This survey also reports that 90 percent of adult cannabis users in the United States said their primary use was recreational, with about 10 percent reporting use solely for medical purposes. Around 36 percent reported mixed medical and recreational use. In addition, between 2002 and 2015, the percentage of past-month cannabis users in the U.S. population ages 12 and older has increased steadily from 6.2 percent to 8.3 percent.

Therapeutic Effects

One of the therapeutic uses of cannabis and cannabinoids is to treat chronic pain in adults. The committee found evidence to support that patients who were treated with cannabis or cannabinoids were more likely to experience a significant reduction in pain symptoms. For adults with multiple sclerosis-related muscle spasms, there was substantial evidence that short-term use of certain “oral cannabinoids” – man-made, cannabinoid-based medications that are orally ingested – improved their reported symptoms. Furthermore, in adults with chemotherapy-induced nausea and vomiting, there was conclusive evidence that certain oral cannabinoids were effective in preventing and treating those ailments.

Injury and Death

Evidence suggests that cannabis use prior to driving increases the risk of being involved in a motor vehicle accident. Furthermore, evidence suggests that in states where cannabis use is legal, there is increased risk of unintentional cannabis overdose injuries among children. In one study, ingestion was the most common route of unintentional pediatric exposure, accounting for 78 percent of all incidents. Another study reported that from 2000 to 2013, the annual rate of poison center calls related to cannabis exposures among children younger than 6 years of age was 2.82 times higher in states that had legalized medical cannabis prior to 2000 than in states where medical cannabis remained illegal as of 2013. The committee called for more research to determine whether and how cannabis use is associated with death or with occupational injury.

Cancer

Regarding the link between marijuana and cancer, the committee found evidence that suggests smoking cannabis does not increase the risk for cancers often associated with tobacco use – such as lung and head and neck cancers. The committee also found limited evidence that cannabis use is associated with one sub-type of testicular cancer and insufficient evidence that cannabis use by a mother or father during pregnancy leads to a greater risk of cancers in the child.

Heart Attack, Stroke, and Diabetes

The committee said that more research is needed to determine whether and how cannabis use is associated with heart attack, stroke, and diabetes. However, some evidence suggests that cannabis smoking may trigger a heart attack.

Respiratory Disease

The evidence reviewed by the committee suggests that smoking cannabis on a regular basis is associated with more frequent chronic bronchitis episodes and worse respiratory symptoms, such as chronic cough and phlegm production, but quitting cannabis smoking is likely to reduce these conditions. The committee stated that it is unclear whether cannabis use is associated with certain respiratory diseases, including chronic obstructive pulmonary disease, asthma, or worsened lung function.

Immunity

There is a lack of data on the effects of cannabis or cannabinoid-based therapeutics on the human immune system, as well as insufficient data to draw overarching conclusions concerning the effects of cannabis smoke or cannabinoids on immune competence, the committee stated. There is also insufficient evidence to support or refute a statistical association between cannabis or cannabinoid use and adverse effects on immune status in individuals with HIV. Nevertheless, limited evidence suggests that regular exposure to cannabis smoke may have anti-inflammatory activity.

Mental Health

The evidence reviewed by the committee suggests that cannabis use is likely to increase the risk of developing schizophrenia, other psychoses, and social anxiety disorders, and to a lesser extent depression. Alternatively, in individuals with schizophrenia and other psychoses, a history of cannabis use may be linked to better performance on learning and memory tasks. Heavy cannabis users are more likely to report thoughts of suicide than non-users, and in individuals with bipolar disorder, near-daily cannabis users show increased symptoms of the disorder than non-users.

Problem Cannabis Use

The evidence reviewed by the committee suggests that with greater frequency of cannabis use, there is an increased likelihood of developing problem cannabis use. There is also evidence to suggest that initiating cannabis use at a younger age increases the likelihood of developing problem cannabis use.

Cannabis Use and the Abuse of Other Substances

The committee found limited evidence that cannabis use increases the rate of initiating other drug use, primarily the use of tobacco. However, the committee found moderate evidence to suggest that there is a link between cannabis use and the development of substance dependence and/or a substance abuse disorder for substances including alcohol, tobacco, and other illicit drugs.

Psychosocial

The committee found that learning, memory, and attention are impaired after immediate cannabis use. Limited evidence suggests that there are impairments in cognitive domains of learning, memory, and attention in individuals who have stopped smoking cannabis. In addition, there is limited evidence to suggest that cannabis use is related to impairments in subsequent academic achievement and education as well as social relationships and social roles. Adolescence and young adulthood are when most youth begin to experiment with substances of abuse, including cannabis, and it is during these periods that the neural layers that underlie the development of cognition are most active. The committee also found limited evidence of an association between cannabis use and increased rates of unemployment and low income.

Prenatal, Perinatal, and Neonatal Exposure

Smoking cannabis during pregnancy is linked to lower birth weight in the offspring, some evidence suggests. However, the relationship with other pregnancy and childhood outcomes is unclear.

Challenges and Barriers in Conducting Cannabis Research

In addition to recommending more research on the beneficial and harmful effects of cannabis and cannabinoid use, the committee emphasized several challenges and barriers in conducting such research. For instance, specific regulatory barriers, including the classification of cannabis as a Schedule I substance, impede the advancement of research. Researchers also often find it difficult to gain access to the quantity, quality, and type of cannabis product necessary to address specific research questions. The committee said a diverse network of funders is needed to support cannabis and cannabinoid research.

The study was sponsored by Alaska Mental Health Trust Authority, Arizona Department of Health Services, California Department of Public Health, Centers for Disease Control and Prevention (CDC), CDC Foundation, U.S. Food and Drug Administration, Mat-Su Health Foundation, National Highway Traffic Safety Administration, National Institutes of Health National Cancer Institute, National Institutes of Health National Institute on Drug Abuse, Oregon Health Authority, Robert W. Woodruff Foundation, The Colorado Health Foundation, Truth Initiative, and Washington State Department of Health. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. The National Academies operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. For more information, visit http://national-academies.org.

 

Category:

Activism, Herbs, Lyme, research, Uncategorized

The Ties that Bind Research Results

http://www.bmj.com/content/356/bmj.i6770

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Abstract

Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding.

Design Cross sectional study of randomized controlled trials (RCTs).

Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013.

Participants Random sample of RCTs focused on drug efficacy.

Main outcome measure Association between financial ties of principal investigators and study outcome.

Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).

Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

https://eurekalert.org/pub_releases/2017-01/b-ftb011617.php

“They stress that their analysis is observational and cannot be used to draw conclusions about causation, but say, given the importance of industry and academic collaboration in advancing the development of new treatments, “more thought needs to be given to the roles that investigators, policy makers, and journal editors can play in ensuring the credibility of the evidence base.”

More research is certainly needed to identify how industry funding and financial ties could influence trial results, say Andreas Lundh from the University of Southern Denmark and Lisa Bero from the University of Sydney in a linked editorial.

They urge trial authors to share their data and participate in industry funded trials only if data are made publicly available – and suggest journals could help by rejecting research by authors who are unwilling to share their data and by penalising authors who fail to disclose financial ties. The role of sponsors, or companies with which authors have ties, in the research must also be transparent.

In the meantime, trials with industry funding or authors with financial ties “should be interpreted with caution until all relevant information is fully disclosed and easily accessible,” they conclude.”

 

 

Category:

research