Ebola
Ebola research shows that rapid control interventions are a key factor in preventing spread. New Ebola research demonstrates that quick and forceful implementation of control interventions are necessary to control outbreaks and avoid far worse scenarios. In a paper published in the journal Eurosurveillance, researchers analyzed up-to-date epidemiological data of Ebola cases in Nigeria as of October 1, 2014, in order to estimate the case fatality rate, proportion of healthcare workers infected, transmission progression, and impact of control interventions on the size of the epidemic.
Researchers used epidemic modeling to project the size of the outbreak in Nigeria if control interventions had been implemented during various time periods after the initial case and estimated how many cases had thus been prevented by early initiation of interventions.
Control measures enacted in Nigeria included all people showing Ebola symptoms being held in an isolation ward if they had contact with the initial case. Once Ebola was confirmed through testing, people with Ebola were moved to a treatment center. Asymptomatic individuals were separated from those showing symptoms, and those who tested negative without symptoms were discharged. People who tested negative but showed symptoms were observed and discharged after 21 days if they were free of symptoms, while being kept apart from people who tested positive for the disease.
“Rapid and forceful control measures are necessary, as is demonstrated by the Nigerian success story. This is critically important for countries in the West African region that are not yet affected by the Ebola epidemic, as well as for countries in other regions of the world that risk importation of the disease,” says Gerardo Chowell, PhD, senior author of the paper.
WHO endorses use of convalescent blood therapies against Ebola. Even as the World Health Organization (WHO) is urging aggressive research into drugs to treat and vaccines to prevent Ebola hemorrhagic virus, it also is sanctioning the use of convalescent blood therapies for people with Ebola—that is, the injection of the whole blood or plasma of Ebola survivors into patients battling the disease. According to WHO, “the use of whole blood therapies and convalescent blood serums needs to be considered as a matter of priority,
To be sure, WHO officials offered cautionary words as well: “Major questions need to be answered about the safety and efficacy of convalescent therapies, and the feasibility of implementation in countries with shattered health systems and an acute shortage of medical staff.” They further note that “some partners and donors are asking for rough estimates of what needs to be in place to support rapid implementation on the largest possible scale….They have questions about the number of staff needed and their training requirements, safety risks and how to manage them, laboratory capacities and how to enhance them, specific needs for equipment and supplies, and what all of this may cost.”
Convalescent blood therapies were used sporadically during the Ebola outbreaks of 1976 and 1995, with mixed and scientifically inconclusive (because there was no control group) results. Reportedly, the technique was used with two of the Americans who were brought to the United States for treatment, in combination with experimental drugs and supportive care. As this issue of MLO goes to press, there are reports that one of those recovered patients, Dr. Kent Brantley, has donated plasma to another patient being treated in the United States for Ebola, NBC cameraman Ashoka Mukpo, who contracted the virus while on assignment in Liberia.
Genomics
NIH issues finalized policy on genomic data sharing. The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products, and procedures that improve health while protecting the privacy of research participants.
Starting with funding applications submitted for a Jan. 25, 2015, receipt date, the policy will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data. This includes research conducted with the support of NIH grants and contracts and within the NIH Intramural Research Program.
The GDS policy can be traced to the Human Genome Project, completed in 2003, which required rapid and broad data release during its mapping and sequencing of the human genome. The GDS policy is an extension of and replaces the Genome-Wide Association Studies (GWAS) data sharing policy.
Since 2007, the GWAS policy has governed biomedical researchers’ submission and access to human data through the NIH database for Genotypes and Phenotypes (dbGaP). Its two-tiered data distribution system has made some information and data available to the public without restrictions. Access to other data has been controlled and made available only for research purposes consistent with the consent provided by participants in the original study.
A key tenet of the GDS policy is the expectation that researchers obtain the informed consent of study participants for the potential future use of their de-identified data for research and for broad sharing. NIH also has similar expectations for studies that involve the use of de-identified cell lines or clinical specimens.
Chemistry
Elevated cholesterol and triglycerides may increase the risk for prostate cancer recurrence. Higher levels of total cholesterol and triglycerides, two types of fat, in the blood of men who underwent surgery for prostate cancer, were associated with increased risk for disease recurrence, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.
“Our findings suggest that normalization, or even partial normalization, of serum lipid levels among men with dyslipidemia [abnormal lipid profile] may reduce the risk of prostate cancer recurrence,” says study co-author Emma Allott, PhD. Allott and colleagues analyzed data from 843 men who underwent radical prostatectomy after a prostate cancer diagnosis and who never took statin medications before surgery. They found that those who had serum triglyceride levels of 150 mg/dL or higher had a 35 percent increased risk for prostate cancer recurrence, when compared with patients who had normal levels of triglycerides. Among those with abnormal blood lipid profile, for every 10 mg/dL increase in total serum cholesterol above 200 mg/dL, there was a nine percent increased risk for prostate cancer recurrence.
For every 10 mg/dL increase in high density lipoprotein (HDL; known as “good” cholesterol) among men with abnormal HDL (below the desirable value of 40 mg/dL), the risk for prostate cancer recurrence was lowered by 39 percent.
“Given that 45 percent of deaths worldwide can be attributed to cardiovascular disease and cancer, with prostate cancer being the second most common cause of male cancer deaths in the United States, understanding the role of dyslipidemia as a shared, modifiable risk factor for both of these common causes of mortality is of great importance,” Allot adds.
Cancer
Circulating tumor cells provide genomic snapshot of breast cancer. Research published in the journal Breast Cancer Research suggests that tumor cells circulating in the blood of metastatic patients could give as accurate a genomic read-out as tumor biopsies. First discovered for their diagnostic potential in 2004, circulating tumor cells are beginning to be used in the clinic to help guide treatment decisions and track a patient’s progress as disease develops. Although other studies have pooled the collected CTCs and compared their genetic signature to that of the primary tumor, this is the first study to look at the genomic signature of individual tumor cells in circulation.
The researchers compared tissue biopsies surgically removed from two patients with inflammatory breast cancer with circulating tumor cells (CTCs). Breast tissue samples from both patients showed a specific mutation in a region of a cancer-driving gene, p53. The authors studied this mutation in several CTCs isolated from both patients. They found that in several of the CTCs collected, the mutations matched with the tumor biopsy. In one patient, some of the circulating tumor cells had an additional mutation.
Although further work analyzing a greater number of genes and samples is needed, the study shows that CTCs offer the possibility of capturing the most current genomic information in an easy-to-obtain sample such as blood, thus helping guide treatment decisions. It also suggests that it may be necessary to test more than one cell for the most accurate reading, as the CTC population appears to be heterogeneous.
Diabetes
The U.S. Preventive Services Task Force has endorsed screening for prediabetes and diabetes. Last month, the Task Force posted a draft recommendation on screening for type 2 diabetes. It recommends that all adults ages 45 and older be screened for diabetes and abnormal blood sugar and recommends the use of hemoglobin A1c testing as a primary method for screening at-risk individuals. Sometime after the formal period of public comment on the draft recommendation and draft evidence review ends November 3, the Task Force will develops its final recommendation and final evidence review.
The Task Force is an independent, volunteer panel of national experts in prevention and evidence-based medicine that works to improve the health of Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications.
New Tests
FDA allows marketing of test to identify yeast pathogens directly from a blood sample. The U.S. Food and Drug Administration (FDA) is allowing the first direct blood test for the detection of five yeast pathogens to be marketed in the United States. The yeast pathogens include Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei, which are known to cause bloodstream infections.
Yeast bloodstream infections are a type of fungal infection that can lead to severe complications and death if not treated rapidly. Traditional methods of detecting yeast pathogens in the bloodstream can require up to six days, and even more time to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) manufactured by T2Biosystems, can identify these five common yeast pathogens from a single blood specimen within three to five hours. Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results.
“By testing one blood sample for five yeast pathogens and getting results within a few hours, physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” says Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.
T2Candida incorporates technologies that break the yeast cells apart, releasing the DNA. It then makes many copies of the target DNA, and detects the amplified DNA using magnetic resonance technology. If yeast DNA is found, T2Candida will also presumptively determine the species category to which it belongs, information that helps to guide healthcare providers to provide appropriate treatment.
