This month’s stories include the launch of National Institutes of Health’s (NIH) new genomic data sharing policy, experts’ ridicule of clinical trials for alternative medicine, and filing of over 1,100 cases of bio-weapon release from wet-labs. In the education sector, the NIH investigates racial disparity in grant applications and US universities see a plunge in Chinese student influx.
Our DNA has the answer to everything – from our disease predispositions to what makes some of us musicians. Since the sequencing of the human genome in 2003, scientists have used genome wide association studies (GWAS) to pinpoint “hot-spots” of variation in our DNA, dubbed SNPs, which put some of us at a higher risk of certain diseases. GWAS performed on patient samples offer valuable clues to the treatment of genetic disorders. In view of this, in 2007 the NIH came up with the GWAS policy to make patient genomic data available to researchers by consolidating it in a database for Genotypes and Phenotypes (dbGaP). Over the past six years, the dbGaP has been used by over 2,200 investigators and resulted in some 900 publications marking significant scientific progress. With its help, scientists have gleaned novel insights into the genetics of cancer, psychiatric illnesses and alcoholism.
Last month, the NIH issued a genomic data sharing (GDS) policy as an extension of the GWAS policy. GDS will take effect from 2015. Until now, investigators de-identified patient information before distributing them to research entities but the new GDS policy requires obtaining the explicit, informed consent of participants when using their genomic data for research. Similar to GWAS, GDS will employ a data-access committee to scrutinise researchers’ data-access requests and be mindful of ethical issues concerning genomic data usage. Additionally, under this policy, the NIH aims to add other genomic data types from both human and non-human studies and make them available to scientists and the public alike.
Unscientific medicine does not deserve clinical trials, experts say
Many of us suffering from a chronic health problem turn to alternative medicine, such as homeopathy or touch therapy. But have we really benefited from these? David Gorsky at Wayne State University School of Medicine, Michigan and Steven Novella at Yale, Connecticut, condemn clinical trials of such dubious forms of medicine.
In the era of evidence-based medicine (EBM), where preclinical research must show clear evidence of the efficacy of a medicine before it is tested on human subjects, alternative medicine like homeopathy and Reiki are based on little to no experimental proof and have abysmally low chances of success. They do not deserve to be tried on valuable human subjects but simply add to the time and cost of randomized clinical trials (RCTs). Homeopathy, for instance, defies the laws of physics as it claims to heal by infinitely diluting chemical compounds to non-existence. Most RCTs using homeopathy have failed and in fact, in one case, the use of diluted toxins mercury and arsenic to treat diarrhea did more harm than good. Similarly, Reiki, a form of touch-therapy, claims that energy can be transferred from a universal source to the patient to facilitate healing. It has a philosophical but no scientific basis. Whether Reiki even has a placebo effect is questionable. The authors suggest that it is time to switch from EBM to science-based medicine, where only those drugs whose mechanism of action is clearly known make it to the RCTs and there is no room for medicine that is derived from pseudoscience.
Accidents happen – mainly due to oversight. But when dealing with dangerous germs that have the capacity to trigger an epidemic, can researchers afford to be careless? Figures show that at least 1100 lab accidents involving bacteria, viruses and toxins were reported to federal agencies between 2008 and 2012.
Researchers working with toxic agents must employ strict biosafety protocols for their handling, storage and disposal as laid down by the Centers for Disease Control and Prevention (CDC). But this summer, there has been a spurt in the release of deadly pathogens from several US labs, the result of shameful negligence on the part of investigators. Lab accidents exposing staff, lab animals and even neighborhood livestock to anthrax, hog cholera or brucellosis are alarming. The instance of an avian flu virus mix-up is probably the most frightening of all. An overworked and rushed scientist contaminated vials of a benign H9N2 strain with a highly virulent variant H5N1, as he failed to clean-up well when switching strains. It is shocking to think of the repercussions of such mistakes – for instance, a lab accident is thought to have set off the H1N1 pandemic in 2009.
CDC has been directed to ramp up security measures, re-assess biosafety levels and reduce the number of select agents in labs as well as the workforce handling them. The incidents have come as ‘wake-up calls’ to biosafety regulators.
NIH investigates racism in grant awards
Statistics show that minority scientists, particularly African American, applying for the NIH grants are only half as successful as the white majority. According to officials, this racial disparity does not reflect any real differences in the competency of the minorities. Rather it may be a sign of a skewed system of evaluation.
To bring fairness into the system, the NIH will be recruiting a team to probe the grant evaluation process starting September. First, the team will anonymize applications. They will strip applicant identifiers, such as name, race, etc., off the applications before they are sent to the reviewers. The drawback here is that some information is hard to conceal viz. the names on publications, which are crucial for the selection process. Second, they will scrutinize reviewers’ comments in successful applications to R01, a major independent research grant, for any trends in their language. One goal here is to get hold of reviewers’ unedited critiques. These may offer clues to any unintentional bias during the review process.
Even if the review process turns out to be unbiased, after all, the NIH believes that these investigations can shed light on racial disparity in the grant-writing process. Minority scientists may simply need more grant-writing practice to have their applications attract reviewers. The outcome, either way, seems to be worthwhile.
When it comes to US schools admissions, a mighty one-third of graduate students has been Chinese, making China the biggest single source of foreign applications. But in recent years, US universities have feared that the scenario may change owing to China’s increasing investment in its own academic infrastructure. From the latest Council of Graduate School’s (CGS) survey, it appears that their fears may come true. For two years in a row, Chinese applications and acceptances numbers have remained flat.
This diminishing trend may be the result of access to world-class training at home, given the Chinese government’s efforts to maximize educational opportunities. According to another theory, it may also stem from a slump in the numbers of degree holders since China raised the bar for college admissions to counter the rise in unemployment rates.
In contrast, Indian applications have boomed by 33% this year after a 22% rise in 2013. Yet another blip in the survey is the huge rise in Brazilian applications, which have shot up by 61% since 2013. In all, the dynamics of foreign applications seem a little unpredictable at the moment.
Originally published at LabTimes