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Summary:
 
Summary:
 
Cyber hacking is very common nowadays.  In order to protect information on your computer or your computer altogether, there are steps to take.  Firstly, one should secure his or her system with an upgraded and updated software.  Secondly, be wary of what you install on your computer to prevent infections, or viruses. Furthermore, know the warning signs. For instance, if your computer is slowing down, it is most often a sign. that your computer is being messed with.  In summary, one should be careful on what is done on one's computer.
 
Cyber hacking is very common nowadays.  In order to protect information on your computer or your computer altogether, there are steps to take.  Firstly, one should secure his or her system with an upgraded and updated software.  Secondly, be wary of what you install on your computer to prevent infections, or viruses. Furthermore, know the warning signs. For instance, if your computer is slowing down, it is most often a sign. that your computer is being messed with.  In summary, one should be careful on what is done on one's computer.
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7/31/18
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'''Tickborne Diseases - Confronting a Growing Threat'''
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Every spring, public health officials prepare for an upsurge in vectorborne diseases. As mosquito-borne illnesses have notoriously surged in the Americas, the U.S. incidence of tickborne infections has risen insidiously, triggering heightened attention from clinicians and researchers. Common Ticks Associated with Lyme Disease in North America. According to the Centers for Disease Control and Prevention (CDC), the number of reported cases of tickborne disease has more than doubled over the past 13 years.1 Bacteria cause most tickborne diseases in the United States, and Lyme disease accounts for 82% of reported cases, although other bacteria (including Ehrlichia chaffeensis, Anaplasma phagocytophilum, and Rickettsia rickettsii) and parasites (such as Babesia microti) also cause substantial morbidity and mortality. In 1982, a spirochete was identified as the causative organism of Lyme disease and was subsequently named Borrelia burgdorferi. B. burgdorferi (which causes disease in North America and Europe) and B. afzelii and B. garinii (found in Europe and Asia) are the most common agents of Lyme disease. The recently identified B. mayonii has been described as a cause of Lyme disease in the upper midwestern United States. Spirochetes that cause Lyme disease are carried by hard-bodied ticks (see graphic), notably Ixodes scapularis in the northeastern United States, I. pacificus in western states, I. ricinus in Europe, and I. persulcatus in eastern Europe and Asia. B. miyamotoi, a borrelia spirochete found in Europe, North America, and Asia, more closely related to the agents of tickborne relapsing fever, is also transmitted by I. scapularis and should be considered in the differential diagnosis of febrile illness occurring after a tick bite. Patterns of spirochete enzootic transmission are geographically influenced and involve both small-mammal reservoir hosts, such as white-footed mice, and larger animals, such as white-tailed deer, which are critical for adult tick feeding. The rising incidence and expanding distribution of Lyme disease in the United States are probably multifactorial, but increased density and range of the tick vectors play a key role. The geographic range of I. scapularis is apparently increasing: by 2015, it had been detected in nearly 50% more U.S counties than in 1996.
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Lyme disease’s clinical manifestations range from relatively mild, nonspecific findings and classic erythema migrans rash in early disease to more severe manifestations, including neurologic disease and carditis (often with heart block) in early disseminated disease, and arthritis, which may occur many months after infection (late disease). Although most cases are successfully treated with antibiotics, 10 to 20% of patients report lingering symptoms after receiving appropriate therapy.2 Despite more than four decades of research, gaps remain in our understanding of Lyme disease pathogenesis, particularly its role in these less well-defined, post-treatment symptoms.  Meanwhile, tickborne viral infections are also on the rise and could cause serious illness and death.1 One example is Powassan virus (POWV), the only known North American tickborne encephalitis-causing flavivirus.3 POWV was recognized as a human pathogen in 1958 after being isolated from the brain of a child who died of encephalitis in Powassan, Ontario. People infected with POWV often have a febrile illness that can be followed by progressive and severe neurologic manifestations, resulting in death in 10 to 15% of cases and long-term sequelae in 50 to 70% of survivors.3 An antigenically similar virus, POWV lineage II, or deer tick virus, was discovered in New England in 1997. Both POWV subtypes are linked to human disease, but their distinct enzootic cycles may affect their likelihood of causing such disease. Lineage II seems to be maintained in an enzootic cycle between I. scapularis and white-footed mice — which may portend increased human transmission, because I. scapularis is the primary vector of other serious pathogens, including B. burgdorferi. Whereas only 20 U.S. cases of POWV infection were reported before 2006,3 99 were reported between 2006 and 2016. Other tickborne encephalitis flaviviruses cause thousands of cases of neuroinvasive illness in Europe and Asia each year, despite the availability of effective vaccines in those regions. The increase in POWV cases coupled with the apparent expansion of the I. scapularis range highlight the need for increased attention to this emerging virus.  The public health burden of tickborne pathogens is considerably underestimated. For example, the CDC reports approximately 30,000 cases of Lyme disease per year but estimates that the true incidence is 10 times that number.1 Multiple factors contribute to this discrepancy, including limitations in surveillance and reporting systems and constraints imposed by available diagnostics, which rely heavily on serologic assays.4 Diagnostic utility is affected by variability among laboratories, timing of specimen collection, suboptimal sensitivity during early infection, imperfect use of diagnostics (particularly in persons with low probability of disease), inability of a single test to identify coinfections in patients with acute infection, and the cumbersome nature of some assays. Current diagnostics also have difficulty distinguishing acute from past infection — a serious challenge in diseases characterized by nonspecific clinical findings. Moreover, tests may remain positive even after resolution of infection, leading to diagnostic uncertainty during subsequent unrelated illnesses. For less common tickborne pathogens such as POWV, serologic testing can be performed only in specialized laboratories, and currently available tests fail to identify novel tickborne organisms.  Such limitations have led researchers to explore new technologies. For example, one of the multiplex serologic platforms that have been developed can detect antibodies to more than 170,000 distinct epitopes, allowing researchers to distinguish eight tickborne pathogens.4 In addition to its utility in screening simultaneously for multiple pathogens, this assay offers enhanced pathogen detection, particularly in specimens collected during early disease. Further studies are needed to determine such assays’ applicability in clinical practice.  Nonserologic platform technologies may also improve diagnostic capabilities, particularly in identifying emerging pathogens. Two previously unknown tickborne RNA viruses, Heartland virus and Bourbon virus, were discovered by researchers using next-generation sequencing to help link organisms with sets of unexplained clinical symptoms. The development and widespread implementation of next-generation diagnostics will be critical to understanding the driving factors behind epidemiologic trends and the full clinical scope of tickborne disease. In addition, sensitive, specific and, where possible, point-of-care assays will facilitate appropriate clinical care for infected persons, guide long-term preventive efforts, and aid in testing of new therapeutics and vaccines.  In the United States, prevention and management of tickborne diseases include measures to reduce tick exposure, such as avoiding or controlling the vector itself, plus prompt, evidence-based treatment of infections. Although effective therapies are available for common tickborne bacteria and parasites, there are none for tickborne viruses such as POWV.  The biggest gap, however, is in vaccines: there are no licensed vaccines for humans targeting any U.S. tickborne pathogen. One vaccine that was previously marketed to prevent Lyme disease, LYMErix, generated an immune response against the OspA lipoprotein of B. burgdorferi, and antibodies consumed by the tick during a blood meal targeted the spirochete in the vector.5 Nonetheless, the manufacturer withdrew LYMErix from the market for a combination of reasons, including falling sales, liability concerns, and reports suggesting it might be linked to autoimmune arthritis, although studies supported the vaccine’s safety. Similar concerns will probably affect development of other Lyme disease vaccines.  Historically, infectious-disease vaccines have targeted specific pathogens, but another strategy would be to target the vector.5 This approach could reduce transmission of multiple pathogens simultaneously by exploiting a common variable, such as vector salivary components. Phase 1 clinical trials are under way to evaluate mosquito salivary-protein–based vaccines in healthy volunteers living in areas where most mosquito-borne diseases are not endemic. Since tick saliva also contains proteins conserved among various tick species, this approach is being explored for multiple tickborne diseases.5. The burden of tickborne diseases seems likely to continue to grow substantially. Prevention and management are hampered by suboptimal diagnostics, lack of treatment options for emerging viruses, and a paucity of vaccines. If public health and biomedical research professionals accelerate their efforts to address this threat, we may be able to fill these gaps. Meanwhile, clinicians should advise patients to use insect repellent and wear long pants when walking in the woods or tending their gardens — and check themselves for ticks when they are done.
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Summary:
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        According to the article, the number of tick borne diseases have emerged highly and there are no vaccines to tackle a specific pathogen.  To begin with, the tick borne diseases are spreading fast.  For instance, the ''B Mayonii'' tick has been described as a cause of the Lyme disease in the upper midwestern United States.  However, due to the awareness and alertness scientists and doctors have, new technology is also being explored.  As stated in the text, "For example, one of the multiplex serologic platforms that have been developed can detect antibodies to more than 170,000 distinct epitopes, allowing researchers to distinguish eight tickborne pathogens."  To sum up, tick borne diseases are more likely to grow if there continues to be a lack of treatment options for those affected.

Revision as of 12:36, 31 July 2018

An Addition to Organs


         Scientists believe that they may have found a possible new organ, the interstitium.  To begin with, the interstitium is a network of tissues that wrap around the digestive tract. However, they rediscovered that there were fluid-filled sacs.   As stated in the document, "When researchers took a closer look at this stuff with out squishing it down, that's when they identified the network of fluid-filled sacs."  Additionally, organs are defined as self-contained and sufficient, but the interstitium isn't an organ yet.  Moreover, if it were an organ, it could help figure out mechanisms in the body that aren't still fully understood.  The author comments, "Understanding better how this system works may enable us to find new ways to treat or prevent all these diseases..."  To sum up, the interstitium may be a useful piece of discovery scientists can observe to become more knowledgeable of the human body.



Fractional-Dose Yellow Fever Vaccination — Advancing the Evidence Base In 2016, a global shortage of yellow fever vaccine occurred as a result of major yellow fever outbreaks in Angola and the Democratic Republic of Congo (DRC). By October, 7136 cases and 493 deaths were reported in the two countries. Reactive vaccination campaigns were conducted in areas with autochthonous transmission during the summer of 2016, but many people were still living in areas of risk. In Kinshasa, the capital of the DRC, a preventive campaign targeting roughly 10.5 million people was needed to mitigate the risk of an urban yellow fever outbreak. However, only 5.8 million vaccine doses were available from the World Health Organization (WHO) stockpile. A solution was urgently needed. Fractionating the available yellow fever vaccine doses and administering a reduced volume of vaccine was one proposal. Faced with the options of using off-label fractional-dose vaccine to meet the supply needs or using the full-dose vaccine but leaving millions of people at risk for yellow fever, the DRC, in close consultation with the WHO, opted to use one fifth of the standard 0.5 ml volume of vaccine (0.1 ml) in its vaccination campaign. More than 7 million people received the fractional-dose vaccine in Kinshasa in August 2016. This decision was based on simple math. WHO-prequalified yellow fever vaccines are highly potent, with average doses between 12,874 and 43,651 international units (IU) — far above the WHO’s recommended minimum of 1000 IU. In principle, the quantity of vaccine virus in fractional doses of standard vaccine would therefore still exceed the WHO’s minimum requirement. But fractionating yellow fever vaccine doses is not without complexity. Average doses vary substantially among vaccine manufacturers and among product batches from a given manufacturer. Fractionating doses from vaccine vials at the lower end of the dosage range could result in doses close to or below the WHO minimum. Furthermore, potency can wane when vaccines are nearing the end of their shelf life, which for WHO-prequalified yellow fever vaccines is 36 months. Even the WHO’s recommended minimum dose must be regarded with some caution, since it is based on studies in animals rather than rigorous dose-finding studies in humans. Thus, it is important to ensure that the immunogenicity of fractional doses is equivalent to that of standard doses of currently used vaccines. At the time of the 2016 outbreak, there were three publications from two studies on the safety and immunogenicity of fractional-dose yellow fever vaccine administered through the recommended route (intramuscular or subcutaneous). Since the older study was based on a vaccine formulation no longer in use, the primary study that informed the WHO recommendations was a dose–response study conducted in Brazil in 2009, using a vaccine produced by Bio-Manguinhos.1 In that study, 900 men were randomly assigned to receive one of six de-escalating doses of the 17DD yellow fever vaccine, ranging from 27,476 to 31 IU. Thirty days after vaccination, seroconversion rates were 97 to 99% for vaccine doses of 587 IU or higher. Among people who originally seroconverted, more than 97% of those who received vaccine doses of 158 IU or higher still had detectable antibodies roughly 10 months after vaccination. An analysis of the cellular immune response showed equivalence to the full dose down to the tested dose of 3013 IU, but not at doses of 587 IU or lower.2 Although these data were considered reassuring, they were restricted to a single country, manufacturer, and population (male adults). In the context of the emergency situation and vaccine shortage, the WHO considered these data sufficient to proceed with a fractional-dose vaccination campaign. Full-dose vaccination was still recommended for young children and pregnant women. The WHO published its official position on fractional-dose yellow fever vaccination in June 2017. The agency recommends fractional-dose vaccination during a yellow fever outbreak only if there is a shortage of full-dose vaccine and emergency-response needs exceed the capacity of the global stockpile. Furthermore, it is still recommended that some groups, such as children less than 2 years of age and pregnant women, receive the full-dose vaccine, given the lack of data demonstrating the safety and immunogenicity of fractional doses. Because of limited data on duration of protection, fractional-dose vaccination also does not qualify people for international travel under the International Health Regulations, a document signed by 196 countries to help the international community prevent and respond to acute public health risks. Without assurances that a fractional-dose vaccine provides the same lifetime protection as a full-dose vaccine, people who receive fractional doses will need to be revaccinated before traveling to countries where yellow fever is endemic and where the International Health Regulations require proof of vaccination. In light of important knowledge gaps related to fractional-dose vaccination, the WHO developed a research agenda to stimulate scientists, policymakers, funders, and industry to address policy-relevant research questions (see box). The global community immediately responded. A small observational study conducted during the August 2016 fractional-dose yellow fever vaccination campaign in the DRC demonstrated 98% seroconversion among people who were seronegative at the time of vaccination.3Participants from the dose-finding study by Bio-Manguinhos1 were reexamined to assess long-term immunogenicity: of 318 participants who seroconverted after vaccination in the original study, 85% were still seropositive 8 years later.4 A randomized noninferiority trial was recently launched comparing seroconversion after fractional-dose and full-dose yellow fever vaccination for each WHO-prequalified vaccine product (ClinicalTrials.gov number, NCT02991495). This study will evaluate fractional-dose vaccination in adults living with HIV and in children. Other studies are examining the immunogenicity of fractional-dose vaccines in children, using various fractional volumes and routes of administration. Use of fractional-dose vaccination in mass vaccination campaigns presents an opportunity to compare the safety of fractional-dose and full-dose yellow fever vaccines — particularly rates of rare, serious adverse events such as vaccine-associated neurotropic and viscerotropic disease. Preliminary data from routine safety monitoring during campaigns involving more than 5 million people in Brazil who received a fractional-dose vaccine are reassuring. The 2016 outbreak in central and southern Africa was a reminder of the delicate supply-and-demand situation for yellow fever vaccines. Beyond the WHO vaccine stockpile, there is limited capacity to respond to demand peaks during larger outbreaks. Limited market incentives and a long manufacturing process requiring embryonated chicken eggs have created barriers to market entry and manufacturing surge capacity. Recently, another vaccine shortage has prompted fractional-dose vaccination campaigns in large cities in Brazil, including areas not previously recognized as being at risk for yellow fever and thus with largely susceptible populations. Although the yellow fever vaccine stockpile is in place to address peaks in demand, it is less suited to cover the surge capacity needed for major urban vaccination campaigns. During the 2016 outbreak, the stockpile was depleted three times. Compounding this problem is the fact that global vaccine coverage is well below the 80% target that is expected to maintain a sufficiently high level of population immunity to eliminate outbreak risk: a recent study estimated that at least 393.7 million people living in high-risk settings (43%) remain unvaccinated.5 International air travel may introduce yellow fever virus to new cities suitable for transmission. The best defense against future vaccine shortages is to achieve adequate routine vaccine coverage in all affected areas. Other countries have considered a broader application of fractional-dose yellow fever vaccination outside emergency shortages. However, core questions remain. Although available evidence supports the use of fractional-dose vaccination when needed, a larger evidence base will be important to ensure optimal use and protection. Ongoing studies will provide much-needed information about specific products, target populations, and duration of protection to strengthen vaccination policies. Continued dialogue and coordination among the policy, research, and funding communities are critical to ensure that when public health emergencies arise, there is sufficient evidence to make robust policy decisions quickly. Policy-driven research agendas are important tools for facilitating such coordination.

Summary:

       In the Democratic Republic of Congo, the yellow fever outbreak emerged a new problem.  To begin with, the vaccine doses  supplied from the World Health Organization (WHO) for 10.5 million people, wasn't enough.  To be clearer, only 5.8 million vaccine doses from the WHO could be supplied because of regulations.  Moreover, the government resolved to fractional - doses of one-fifth of the standard 0.5 ml volume of the vaccine, or 0.1 ml.  However, fractional - doses should be used with caution.  As stated in the text, "Average doses vary substantially among vaccine manufacturers and among product batches.."  This sparked more studies to be conducted on the immunogenicity of fractional - doses.  In conclusion, global vaccine coverage isn't enough for situations like this.



Oropharyngeal Tularemia from Freshly Pressed Grape Must In high-income countries, oropharyngeal tularemia is associated with hunting or eating infected game or drinking contaminated water.1,2 We describe a cluster of cases of oropharyngeal tularemia that appears to have been caused by the consumption of freshly pressed grape must by grape harvesters volunteering at a vineyard in Rhineland-Palatinate, Germany, in October 2016. At this vineyard, owned by vintner 1, the grapes were collected mechanically (sort 1A) and by hand (sort 1B), and each lot was pressed separately. After the grapes were pressed, the harvesters tasted the fresh must from sort 1A. The same mechanical harvester was then used to collect grapes at another vineyard (owned by vintner 2). These grapes (sort 2C) were processed at a winery owned by vintner 2. Apart from the mechanical harvester used to collect the grapes, there was no link between the wineries owned by vintners 1 and 2. Among the total of 29 harvesters who worked for vintner 1, six harvesters — two women and four men (median age, 24.5 years; interquartile range, 10.3 to 39.5) — became ill, with swollen cervical lymph nodes, fever, chills, difficulty swallowing, and diarrhea, within 4 to 8 days after the suspected exposure. In each of these six harvesters, antibodies to the Francisella tularensis lipopolysaccharide were detected on enzyme-linked immunosorbent assay, a finding that was confirmed on Western blot analysis (for additional details on the tests used, see the Supplementary Appendix, available with the full text of this letter at NEJM.org).3 We interviewed vintner 1 and visited his vineyard and his winery 1 to recreate the events that occurred during the harvest. In addition, we obtained samples of the new wine from both vintners: sorts 1A and 1B, from vintner 1, and sort 2C, from vintner 2. We conducted a retrospective cohort study and defined cases as those in which there was laboratory-confirmed tularemia with onset of self-reported symptoms up to 14 days after the event. Serologic testing was offered to all harvesters, and a structured questionnaire was used to ascertain potential exposures and symptoms among all participants. This study was conducted within the legal mandate of the Landesuntersuchungsamt Rheinland-Pfalz, Koblenz, and the Robert Koch Institute, Berlin, both in Germany. Table 1. Risk Factors for Seropositive Oropharyngeal Tularemia in a Cohort of Grape Harvesters, October 2016. Incidence risk ratios were calculated with the use of Poisson regression (for details, see the Supplementary Appendix). In the multivariable analysis, we found that drinking fresh must from sort 1A was the only significant predictor for the acquisition of tularemia (incidence risk ratio calculated with exact Poisson regression = 13.5; P=0.01) (Table 1). The attack rate for drinking fresh must was 75% (6 of 8 harvesters), which in turn could explain 100% of the cases (6 of 6). Table 2. Results of Environmental Testing of New Wine for the Francisella tularensis Gene Tul4. DNA from F. tularensis subspecies holarctica was identified by means of polymerase-chain-reaction (PCR) assay and its content quantified in new wine made from grapes pressed on the same day (Table 2). Grapes from sort 1B (in which 440 genome equivalents per milliliter were detected) were pressed after those from sort 1A (16,849 genomic equivalents per milliliter), which suggests that cross-contamination occurred in the press at winery 1. In the winery owned by vintner 2, 1 genomic equivalent per milliliter was identified in sort 2C, which had been pressed from grapes collected by the same mechanized harvester used earlier that same day by vintner 1, a finding that suggests that the harvester was the source of cross-contamination. On the basis of quantitative PCR results, we estimated that 109 to 1010 bacteria had contaminated 730 liters of must pressed from the grapes in sort 1A, indicating substantial contamination with F. tularensis. Sequencing analyses provided evidence of DNA from wood mice (apodemus species) in wine made from sort 1A, and vintners confirmed the occasional presence of rodents in mechanically collected grapes. We infer that an infected rodent may have been collected by the harvester and pressed with the grapes in sort 1A, thereby infecting humans through contaminated must. This outbreak suggests that mechanical harvesting can be a risk factor for the transmission of zoonoses such as tularemia and that raw food stuffs should be treated before consumption. In this instance, all contaminated products were confiscated and their sale prohibited by public health and other local authorities.4,5

Summary:

         Six harvesters fell ill of "tularensis" in a vineyard.  Firstly, there was an occurrence of cross-contamination in Winery 1.  For instance, a harvester was the source of the cause of the cross-contamination from drinking must.  According to the text, "In the multivariable analysis, we found that drinking fresh must from sort 1A was the only significant predictor for the acquisition of tularemia..."  An inference was made that an infected rodent may have been pressed in with the grapes by the same harvester who drank the fresh must.  As stated in the text, "We infer that an infected rodent may have been collected by the harvester and pressed with the grapes in sort 1A, thereby infecting humans through contaminated must."  Therefore, mechanical harvesting can be a risky factor in which the transmission of a disease from animals to humans.

7/18/18 "A Parallel Universe of Clinical Trials"
A recent clinical trial of a herpes simplex virus vaccine allegedly violated fundamental scientific, regulatory, and ethical safeguards. This case opens a window into a parallel universe that spurns the current system of clinical trial oversight in the United States and supports broad right-to-try laws allowing patients access to experimental therapies.

A faculty member at Southern Illinois University, William Halford, who had a Ph.D. in immunology and microbiology, injected volunteers with a live attenuated herpes simplex virus vaccine he had developed, without approval from an institutional review board (IRB), submission of an investigational new drug application to the Food and Drug Administration (FDA), or formal informed consent from participants, according to investigative journalists.1 Halford administered the vaccine first to himself and later allegedly to participants in a hotel off campus. In 2016, the 17 participants were flown to St. Kitts and Nevis for vaccine injections. Results of the trial have not been published in a peer-reviewed journal. Halford died of cancer in 2017. The trial sponsor, a company called Rational Vaccines, was cofounded by Halford and the Oscar-winning producer Agustín Fernández III. According to Fernández, working in the film industry is good training for running a nontraditional pharmaceutical company because it requires thinking outside the box. Peter Thiel, the technology entrepreneur and investor and outspoken critic of the FDA, invested in the company; he stipulated, however, that future studies adhere to FDA requirements. After Kaiser Health News broke the story of the vaccine trial and Senator Chuck Grassley (R-IA) prodded the federal Office for Human Research Protections, the university launched an investigation. To date, Southern Illinois University — which holds the patent on the vaccine — has admitted serious noncompliance with university policies and federal regulations but says the investigator hid his actions from the school. Its investigation continues, and the FDA has reportedly opened a criminal investigation into Halford’s research. The government of St. Kitts and Nevis said that required approvals had not been obtained, and it is conducting its own investigation. Although no deaths or hospitalizations have been reported among trial participants, three participants have sued the study sponsor. Another participant said that after he received the vaccine series, his herpes outbreaks decreased in frequency and intensity and eventually stopped.2 Rational Vaccines, whose website currently has no content, told a journalist that it will continue to develop the vaccine and seek approval in countries around the world while following “international good clinical practice standards.” This clinical trial allegedly violated two fundamental standards for protecting research participants: IRB approval of the trial protocol and informed consent from participants. Before a trial can proceed, an IRB must determine that the risks to participants are reasonable and minimized through the use of sound research design and also must approve a consent form that covers topics specified in FDA regulations. These standards are required by the FDA for clinical trial protocols submitted to support marketing of new products and by the Good Clinical Practice guidelines, which harmonize regulations in the United States, the European Union, and Japan. Like most institutions, Southern Illinois University requires that all research involving human participants carried out by its faculty and staff must comply with federal regulations regarding protection of human subjects, including research that is not federally funded or is conducted off campus. Although many people in the biomedical field support reducing regulatory burdens for new therapies, the Halford case has triggered calls to abolish IRB review and radically redefine consent for clinical trials. A parallel free-market and libertarian universe staunchly defends the herpes vaccine trial, its principal investigator, and its rationale. Supporters of this movement make several arguments. First, they contend that patients should have the liberty to make their own decisions about research participation, without experts or government officials trying to “protect” them. An article on the website of the free-market group Foundation for Economic Education declares that the current drug-approval system “assumes that you and your doctor are not smart enough to access relevant data and make informed decisions about the use of not-yet-approved drugs, decisions attuned to your unique health conditions and preferences.”3 Second, they argue that current FDA and IRB regulations harm patients by stifling and delaying innovative new treatments in order to protect vested interests, including those of established scientists and research institutions. Under the current administration, these libertarian ideas are driving policy. Right-to-try laws backed by the Goldwater Institute have been enacted nationally and in most states. The free-market Heartland Institute, which supports the herpes vaccine trial and its investigator, urges sweeping deregulation of new therapies. Before the passage of the federal right-to-try law, leaders of the institute wrote, “Many of those cheering this pending legislation have been working to restructure the FDA’s monopoly on access to new drugs far beyond just the terminally-ill patients covered by Right To Try.”4 Third, supporters of Halford believe that scientists whose work has been rejected by peer reviewers or who violate regulatory requirements are courageous heroes. The president of the Foundation for Economic Education praised Halford as “a genius who challenged conventional wisdom, blazed new trails in scientific research, dedicated his life to helping others, developed promising new tools against a terrible affliction, and lighted a path for the policy changes needed to end the suffering of millions.”5 According to these arguments, researchers’ assertions about proposed treatments can replace peer review, even when their claims lack supporting trustworthy evidence. Advocates of evidence-based standards for new therapies might dismiss libertarian and free-market arguments for dismantling these standards. But the latter views are politically ascendant today. An effective response would heed valuable lessons from the groups that embrace such views. To gain broader public support, the medical research community should listen to and respond to the concerns that lead patients to seek untested therapies, including deep frustration over the lack of effective treatments, perceived disrespect, and marginalization of their needs. Libertarian groups have tapped into such emotions effectively. The community could develop a memorable and succinct mission statement — perhaps something like, “getting patients and their physicians the information they need to decide on treatments.” Making the case for evidence-based standards for new treatments in terms the public understands is also important. Personal stories and cases can grip the attention of readers or listeners, as disease advocacy groups have demonstrated. The plight of patients who need better treatments must then be connected to the need for credible information about the effectiveness and safety of proposed treatments. Evidence-based standards are tools to help patients and their physicians decide whether claims about a given treatment are supported by data. To make informed decisions, patients need access to the protocols and main results of all pertinent clinical trials, including trials that are unpublished or did not favor the intervention. Finally, although scientists might balk at reducing complex issues to short and simple points, effective communication has helped libertarian and free-market advocates change laws. Such groups strategically target crucial stakeholders, including state and federal legislators, and work with like-minded organizations. Supporters of evidence-based medicine should do the same. Partnering with patient-oriented groups such as the Michael J. Fox Foundation, the Parker Institute for Cancer Immunotherapy, and the Genetic Alliance can broaden support for sound evidence regarding potential new treatments. Such organizations, which are accelerating drug development, have substantial public credibility and cannot be criticized as protecting the vested interests of scientists, research institutions, or drug companies. The Halford case is one example of ongoing zealous attacks on standards for clinical trials. In response, champions of evidence-based standards for new therapies must convincingly demonstrate that they are addressing patients’ needs. Otherwise, their views will not resonate with the public. Summary: Clinical trials prove helpful and informational, but also controversial. William Halford, a member at Southern Illinois University, began an experiment on volunteers without permission, or consent from an institutional review board (IRB), Food and Drug Administration, or formal consent from the volunteers, according to journalists. Halford died in 2017 to cancer without publishing the results of the trial and his participants. Moreover, formal consent is needed whenever conducting an experiment, especially on patients or volunteers. These are needed because there are laws and fundamental standards for protecting patients. For instance, one needs approval from the IRB, informed consent from the participants, and to inform the risks to the participant before the start of a trial. as stated in the text, "This case opens a window into a parallel universe that spurns the current system of clinical trial oversight in the United States and supports broad right-to-try laws allowing patients access to experimental therapies." Therefore, one should research on what to do before performing clinical trials.


How To Make Sure No One Is Spying On Your Computer A program that spies on your computer activity is one of the most dangerous forms of malware. It won't present you with a ransomware request or announce it's deleting your files. Instead, it hides silently on your system, watching and recording all your computer activity. Spyware can do everything from hijacking your webcam feed to recording your keyboard inputs. The culprits ultimately aim to collect enough of your personal data to steal your identity, take over your accounts, or expose your digital life in other ways. To minimize the odds of an unwanted program taking root on your machine, follow our guide to staying spyware-free. Secure your system To start with, you need to establish solid protection for your computer. Most antivirus programs for both Windows and macOS will protect against keyloggers, webcam hackers, and other types of spyware, especially if you vigilantly keep this software up to date. How do you choose? You won't find a "one size fits all" security solution for everyone. For most home computers, free software should provide adequate level of protection, but paying for an upgraded version of the program will increase your chances of staying safe. We chose four of the most effective and intuitive free antivirus tools we've used in recent years. They all receive high scores from AV-Comparatives, an organization that independently assesses antivirus software, even compared to excellent fee-based programs like Avira and McAfee. Although none of the following options specializes in fighting spyware, all of them include some defenses against that type of malicious program. As long as you install any one of these packages, you'll massively reduce your system's risk of infection. Our picks are Windows Defender (included with Windows 10), AVG Free (for Windows and macOS, upgraded version costs $70/year), Bitdefender (for Windows, upgraded version includes macOS support and costs $54/year), Malwarebytes (for Windows, upgraded version includes macOS support and costs $40/year), and Avast (for Windows and macOS, upgraded version costs $60/year). If you upgrade these programs to paid-for versions, you'll gain extras like enhanced web-link scanning to catch dodgy URLs, more comprehensive options for proactively preventing attacks, and secure file storage. Alongside your main security product, we recommend that you install secondary protection. For Windows, we like the free Spybot Search & Destroy, which works alongside your regular antivirus package, performing deep scans as an extra layer of defense against infectious code. If you suspect that your computer suffers from spyware, but your normal antivirus tool doesn't pick it up, try digging deeper into your system with the secondary Windows security program Norton Power Eraser. In a similar vein, Trend Micro's HouseCall serves as an extra scanner on top of your current security package, and it works from your web browser, which allows it to cover any type of operating system. oid infection Even with a strong antivirus program in place, you don't want to give spyware a chance to hitch a ride on your computer. If you want to keep prying eyes off your system, then you need to monitor all the potential ways malicious code can worm its way into your machine. Sadly, some spyware enters through the household, when people attempt to pry into the computer behavior of their friends and family members. While we're sure everyone in your home is perfectly trustworthy...a shared computer should still have separate user accounts for each person who relies on that machine. Protect those accounts with passwords to keep out snoops: In Windows, do this in Settings > Accounts; in macOS, check the setting in System Preferences > Users & Groups. Other programs arrive in disguise, purporting to be random web pop-ups or harmless email messages. They often hide within applications that look perfectly legit, or appear to be email attachments in a file format you recognize. Be wary of links you receive over social media or email, even if they appear to come from people you trust—a bad actor may have compromised their accounts or spoofed their identities. Here are a few ways to protect yourself from fraudulent links, which may contain spyware. In addition, you need to be very careful about what you install on your computer, and where you download it from. If you want to try a new piece of software, make sure to read up on it first. And when you're ready to install the program, make sure you get it from the official website of the software company that designs it, or stick to programs that you can download from the Mac or Windows Store. The same goes for browser extensions. Giving these tools access to your browser can compromise its security, so you need to vet add-ons carefully. Before you install anything, check the reviews left by other users, or search for it to see if it has endorsements from professional tech sites. Know the warning signs No matter how tight you make your system's defenses, you shouldn't get complacent. In addition to taking the aforementioned precautions against infection, keep an eye out for these signs of spyware's presence. One red flag is a system that runs sluggishly. Of course, older computers slow down gradually over time, but watch for a sudden drop in performance. Also keep an eye out for a lot of hard drive activity and software pauses, especially if they happen even when your computer is not running a lot of programs. In general, you should treat strange and unexpected behavior—such as the launch of applications that you didn't open directly—with suspicion. This is no big deal if you've set programs to open automatically when the computer turns on, but it could be problematic if this happens when you're in the middle of a session. It's particularly suspect if windows appear briefly and then disappear again, a sign of a program loading and then hiding itself. Every spyware program and system setup is different, so we can't really give you a definitive checklist; but the more suspicious occurrences you notice, the more likely it is that your computer has been infected. Other odd actions include unexplained mouse movements or text input, which might be a sign of something unknown working in the background; changes to the settings of the operating system; and the appearance of application shortcuts that you haven't noticed before. Spyware will try to run invisibly, but it will still use up memory and CPU time. So you should check what programs and processes are running on your computer. On a Windows machine, you can use Task Manager, which you launch by searching for it in the taskbar box. Then switch to the Processes tab to see all the applications and processes currently in memory. On macOS, take advantage of a similar tool called Activity Monitor, which you can find by opening Spotlight (hit the Cmd+Space keyboard shortcut) and searching for Activity Monitor. Under the CPU tab you'll see a list of programs and processes currently running, as well as how much of your computer's system resources they're taking up. What should you look for in Task Manager or Activity Monitor? Annoyingly, malicious tools frequently have names that look as innocuous as possible. This means we can't give you a definitive list of terms that indicate spyware. Instead, keep an eye out for applications or processes that you don't recognize or remember launching, then do a quick web search for their names to find out if they're legitimate or not. The good news is that even as spyware becomes smarter and more sophisticated, browsers and operating systems are including more security tools. Still, you should always keep your system, its programs, and its security tools up to date with the latest patches.

Summary: Cyber hacking is very common nowadays. In order to protect information on your computer or your computer altogether, there are steps to take. Firstly, one should secure his or her system with an upgraded and updated software. Secondly, be wary of what you install on your computer to prevent infections, or viruses. Furthermore, know the warning signs. For instance, if your computer is slowing down, it is most often a sign. that your computer is being messed with. In summary, one should be careful on what is done on one's computer.


7/31/18 Tickborne Diseases - Confronting a Growing Threat Every spring, public health officials prepare for an upsurge in vectorborne diseases. As mosquito-borne illnesses have notoriously surged in the Americas, the U.S. incidence of tickborne infections has risen insidiously, triggering heightened attention from clinicians and researchers. Common Ticks Associated with Lyme Disease in North America. According to the Centers for Disease Control and Prevention (CDC), the number of reported cases of tickborne disease has more than doubled over the past 13 years.1 Bacteria cause most tickborne diseases in the United States, and Lyme disease accounts for 82% of reported cases, although other bacteria (including Ehrlichia chaffeensis, Anaplasma phagocytophilum, and Rickettsia rickettsii) and parasites (such as Babesia microti) also cause substantial morbidity and mortality. In 1982, a spirochete was identified as the causative organism of Lyme disease and was subsequently named Borrelia burgdorferi. B. burgdorferi (which causes disease in North America and Europe) and B. afzelii and B. garinii (found in Europe and Asia) are the most common agents of Lyme disease. The recently identified B. mayonii has been described as a cause of Lyme disease in the upper midwestern United States. Spirochetes that cause Lyme disease are carried by hard-bodied ticks (see graphic), notably Ixodes scapularis in the northeastern United States, I. pacificus in western states, I. ricinus in Europe, and I. persulcatus in eastern Europe and Asia. B. miyamotoi, a borrelia spirochete found in Europe, North America, and Asia, more closely related to the agents of tickborne relapsing fever, is also transmitted by I. scapularis and should be considered in the differential diagnosis of febrile illness occurring after a tick bite. Patterns of spirochete enzootic transmission are geographically influenced and involve both small-mammal reservoir hosts, such as white-footed mice, and larger animals, such as white-tailed deer, which are critical for adult tick feeding. The rising incidence and expanding distribution of Lyme disease in the United States are probably multifactorial, but increased density and range of the tick vectors play a key role. The geographic range of I. scapularis is apparently increasing: by 2015, it had been detected in nearly 50% more U.S counties than in 1996. Lyme disease’s clinical manifestations range from relatively mild, nonspecific findings and classic erythema migrans rash in early disease to more severe manifestations, including neurologic disease and carditis (often with heart block) in early disseminated disease, and arthritis, which may occur many months after infection (late disease). Although most cases are successfully treated with antibiotics, 10 to 20% of patients report lingering symptoms after receiving appropriate therapy.2 Despite more than four decades of research, gaps remain in our understanding of Lyme disease pathogenesis, particularly its role in these less well-defined, post-treatment symptoms. Meanwhile, tickborne viral infections are also on the rise and could cause serious illness and death.1 One example is Powassan virus (POWV), the only known North American tickborne encephalitis-causing flavivirus.3 POWV was recognized as a human pathogen in 1958 after being isolated from the brain of a child who died of encephalitis in Powassan, Ontario. People infected with POWV often have a febrile illness that can be followed by progressive and severe neurologic manifestations, resulting in death in 10 to 15% of cases and long-term sequelae in 50 to 70% of survivors.3 An antigenically similar virus, POWV lineage II, or deer tick virus, was discovered in New England in 1997. Both POWV subtypes are linked to human disease, but their distinct enzootic cycles may affect their likelihood of causing such disease. Lineage II seems to be maintained in an enzootic cycle between I. scapularis and white-footed mice — which may portend increased human transmission, because I. scapularis is the primary vector of other serious pathogens, including B. burgdorferi. Whereas only 20 U.S. cases of POWV infection were reported before 2006,3 99 were reported between 2006 and 2016. Other tickborne encephalitis flaviviruses cause thousands of cases of neuroinvasive illness in Europe and Asia each year, despite the availability of effective vaccines in those regions. The increase in POWV cases coupled with the apparent expansion of the I. scapularis range highlight the need for increased attention to this emerging virus. The public health burden of tickborne pathogens is considerably underestimated. For example, the CDC reports approximately 30,000 cases of Lyme disease per year but estimates that the true incidence is 10 times that number.1 Multiple factors contribute to this discrepancy, including limitations in surveillance and reporting systems and constraints imposed by available diagnostics, which rely heavily on serologic assays.4 Diagnostic utility is affected by variability among laboratories, timing of specimen collection, suboptimal sensitivity during early infection, imperfect use of diagnostics (particularly in persons with low probability of disease), inability of a single test to identify coinfections in patients with acute infection, and the cumbersome nature of some assays. Current diagnostics also have difficulty distinguishing acute from past infection — a serious challenge in diseases characterized by nonspecific clinical findings. Moreover, tests may remain positive even after resolution of infection, leading to diagnostic uncertainty during subsequent unrelated illnesses. For less common tickborne pathogens such as POWV, serologic testing can be performed only in specialized laboratories, and currently available tests fail to identify novel tickborne organisms. Such limitations have led researchers to explore new technologies. For example, one of the multiplex serologic platforms that have been developed can detect antibodies to more than 170,000 distinct epitopes, allowing researchers to distinguish eight tickborne pathogens.4 In addition to its utility in screening simultaneously for multiple pathogens, this assay offers enhanced pathogen detection, particularly in specimens collected during early disease. Further studies are needed to determine such assays’ applicability in clinical practice. Nonserologic platform technologies may also improve diagnostic capabilities, particularly in identifying emerging pathogens. Two previously unknown tickborne RNA viruses, Heartland virus and Bourbon virus, were discovered by researchers using next-generation sequencing to help link organisms with sets of unexplained clinical symptoms. The development and widespread implementation of next-generation diagnostics will be critical to understanding the driving factors behind epidemiologic trends and the full clinical scope of tickborne disease. In addition, sensitive, specific and, where possible, point-of-care assays will facilitate appropriate clinical care for infected persons, guide long-term preventive efforts, and aid in testing of new therapeutics and vaccines. In the United States, prevention and management of tickborne diseases include measures to reduce tick exposure, such as avoiding or controlling the vector itself, plus prompt, evidence-based treatment of infections. Although effective therapies are available for common tickborne bacteria and parasites, there are none for tickborne viruses such as POWV. The biggest gap, however, is in vaccines: there are no licensed vaccines for humans targeting any U.S. tickborne pathogen. One vaccine that was previously marketed to prevent Lyme disease, LYMErix, generated an immune response against the OspA lipoprotein of B. burgdorferi, and antibodies consumed by the tick during a blood meal targeted the spirochete in the vector.5 Nonetheless, the manufacturer withdrew LYMErix from the market for a combination of reasons, including falling sales, liability concerns, and reports suggesting it might be linked to autoimmune arthritis, although studies supported the vaccine’s safety. Similar concerns will probably affect development of other Lyme disease vaccines. Historically, infectious-disease vaccines have targeted specific pathogens, but another strategy would be to target the vector.5 This approach could reduce transmission of multiple pathogens simultaneously by exploiting a common variable, such as vector salivary components. Phase 1 clinical trials are under way to evaluate mosquito salivary-protein–based vaccines in healthy volunteers living in areas where most mosquito-borne diseases are not endemic. Since tick saliva also contains proteins conserved among various tick species, this approach is being explored for multiple tickborne diseases.5. The burden of tickborne diseases seems likely to continue to grow substantially. Prevention and management are hampered by suboptimal diagnostics, lack of treatment options for emerging viruses, and a paucity of vaccines. If public health and biomedical research professionals accelerate their efforts to address this threat, we may be able to fill these gaps. Meanwhile, clinicians should advise patients to use insect repellent and wear long pants when walking in the woods or tending their gardens — and check themselves for ticks when they are done. Summary:

       According to the article, the number of tick borne diseases have emerged highly and there are no vaccines to tackle a specific pathogen.  To begin with, the tick borne diseases are spreading fast.  For instance, the B Mayonii tick has been described as a cause of the Lyme disease in the upper midwestern United States.  However, due to the awareness and alertness scientists and doctors have, new technology is also being explored.  As stated in the text, "For example, one of the multiplex serologic platforms that have been developed can detect antibodies to more than 170,000 distinct epitopes, allowing researchers to distinguish eight tickborne pathogens."  To sum up, tick borne diseases are more likely to grow if there continues to be a lack of treatment options for those affected.