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Science Policy Around the Web – April 18, 2017

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By: Nivedita Sengupta, PhD

Source: pixabay

DNA Testing

23andMe Given Green Light to Sell DNA Tests for 10 Diseases

On April 6th, the US Food and Drug Administration (FDA) approved the first at-home genetic test kits, which can be sold over the counter in pharmacies, to determine the risk of developing certain genetic diseases. Since 2006, 23andMe, a company based in California, has been analyzing DNA from saliva samples of its customers to provide genetic insights into their risk of developing 240 different diseases and disorders. However, in 2013, FDA was concerned about customers using test results to make medical decisions on their own, and ordered 23andMe to halt the service. In 2015, FDA eased some of the restrictions and allowed the company to reveal to their customers only the information regarding genetic anomalies that can be transferred to their children, and not any information about the person’s own disease risk.

23andMe now has permission to inform its customers about genetic mutations that are strongly associated with a small group of medical conditions such as Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease and a hereditary blood-clot disorder called thrombophilia. However, it should be noted that the results from these tests are not equivalent to a medical diagnosis, as the development of a disease is also influenced by a person’s family history, lifestyle and environment.

The decision made by the FDA paves the way for a wave of do-it-yourself diagnostic tests, which will be flooding the market in the coming years. “It’s a watershed moment for us and the FDA,” says Kathy Hibbs, chief legal and regulatory officer at 23andMe. However, there are concerns regarding the limits of medical knowledge among common people to understand and interpret the results and the limitations of these tests, which could lead to misinterpretation of the results and complications. (Amy Maxmen, Nature News)

Neonatal Care

Giving Newborns Medicine is a Dangerous Guessing Game. Can We Make it Safer?

Medical emergencies in neonates are on the rise. It might be surprising for many parents to know that 90% of the medications administered in a neonatal intensive care unit are not medically approved by the FDA for use in newborns. Neonates are routinely treated with drugs that are not adequately tested for safety, dosing, or effectiveness. This is a global problem, and many factors contribute to it. Firstly, parents and doctors are afraid of enlisting newborns in clinical trials. Secondly, pharmaceutical companies are afraid to test drugs on neonates as the risk of liability is very high. It is also a small market, so pharmaceutical companies may not make money by getting drugs approved for neonates.

In 2015, an FDA funded nonprofit organization launched two global efforts to encourage clinical trials in newborns. One of which is the International Neonatal Consortium (INC), which published a guide to clinical trials in neonates last year. Dr. Jonathan Davis, Director of INC said, “We’ve got to do something.” Without information on drug data for newborns, “we can’t be certain which drugs, in which doses, to use when.” Under the current system, doctors are making decisions based on either anecdotes or intuition, which essentially means that every sick newborn is an uncontrolled, unapproved study without the guarantee of seeing improvement. No data collection is done, thus not providing any information for treating other infants around the world.

Physicians often take decisions by scaling down from how medications are used in adults. But this can be fatal and lead to disasters as we have seen in the past, with the use of the antibiotic chloramphenicol in the 1950s, and the preservatives benzyl alcohol and propylene glycol in the 1980s. Infants are not tiny adults, and they adsorb, metabolize, and excrete drugs in different ways than adults. The majority of studies done in neonates in recent years have not been able to establish efficacy. More studies need to be done, and this requires proper designing of clinical trials with reduced risk, and eliminating unnecessary interventions. (Megan Scudellari, STATNews)

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Written by sciencepolicyforall

April 18, 2017 at 10:45 am

Science Policy Around the Web – June 4, 2013

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By: Jennifer Plank

photo credit: NCinDC via photopin cc

photo credit: NCinDC via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Supreme Court upholds Maryland law, says police may take DNA samples from arrestees – On Monday, the Supreme Court decided the case King v. Maryland and ruled that police officers can collect DNA samples upon arrest just as it takes mugshots and fingerprints. The case originated in 2009 when John King was convicted of a 2003 rape after a DNA sample was obtained following an assault charge. The Supreme Court ruling will reinstate the rape charge against King. Justice Kennedy, who wrote the opinion for the majority, stated that the ruling is limited in scope- DNA can only be collected from suspects who are arrested for “serious crimes”. (Robert Barnes)

Greece’s 200% increase in HIV shows how dangerous austerity can be for public health – European health and finance officials met in March to determine how healthcare systems are doing following severe budget cuts. Evdoxia Andrianopoulou, a Greek financial ministry official, presented data showing the steep budget cuts made to the Greek healthcare system. Included in budget cuts was the reduction of the mosquito spraying program, and consequently, an increase in the number of malaria outbreaks. Additionally, the number of new HIV infections increased 200 percent due to a reduction in funds for Greece’s clean needle program.  (Michael Scaturro)

NIH fact sheet lays out sequester impact – Following implementation of sequestration, the NIH has detailed how the Institutes will absorb the $1.55 billion budget cut. The cuts were applied across all institutes and programs meaning that every niche of biomedical research will feel the cuts. Briefly, the NIH will award approximately 700 fewer grants, training grant stipends will be frozen, approximately 750 fewer patients will be admitted to the clinical center, and ongoing grants will have their budgets reduced 4.7%. The intramural program will have to implement 5% budget cuts over the second half of the fiscal year. (Jocelyn Kaiser)

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Written by sciencepolicyforall

June 4, 2013 at 4:08 pm