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Archive for September 2018

Science Policy Around the Web – September 28, 2018

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By: Emily Petrus, Ph.D

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Healthcare Coverage

Why Chinese medicine is heading for clinics around the world

The World Health Organization (WHO) has an agenda to expand access to healthcare across the globe. Western medicine is often too expensive and inaccessible for people in underdeveloped countries. These factors combined with a global distrust of pharmaceutical companies and products sets the stage for a new wave of medical diagnoses and treatments based on traditional Chinese medicine (TCM). The World Health Assembly recently updated the International Statistical Classification of Diseases and Related Health Problems (ICD) for the 11th edition to include TCM. This document is used by doctors, insurance companies and epidemiologists to make healthcare and reimbursement decisions.

Included in the ICD-11are over 3,000 terms to standardize TCM diagnoses and treatments, and contains information from Asian countries including China, South Korea and Japan. Proponents of TCM argue that the low costs and increased availability make it an effective and sustainable medical treatment option. Occasionally the plants used in TCM have been discovered to contain molecules which make treatments effective – the 2015 Nobel Prize in Physiology or Medicine went to Youyou Tu for the discovery of an antimalaria treatment based on TCM. Critics maintain that large, randomized clinical trials often find that TCM is ineffective at treating illnesses, and can often lead to adverse effects like kidney failure or even cancer. In the middle of the debate are researchers like those at the National Center for Complementary and Integrative Health at the National Institutes of Health in Bethesda, Maryland, who agree that while some treatments may be effective, more careful trials must be performed. For example, Catherine Bushnell’s group at NCCIH has published evidence that people who practice yoga have higher pain tolerances. The hope is that the updated ICD-11 will standardize TCM descriptions of disease nomenclature, symptoms, and treatments. This in turn can create the basis for reproducible clinical trials to test efficiency to satisfy critics.

Seventy percent of healthcare spending is reimbursed by insurance or social healthcare networks based on information contained in the ICD. It is likely that TCM will be readily adopted by insurance because the costs are generally low compared to western medicine. Already in China a national strategy has been developed to deliver TCM to the entire population by 2020. In addition, TCM tourism has caused an industry boom in China, where tens of thousands of patients arrive to centers designed to cater to these patients. The monetary gain for those practicing TCM is hard to ignore: $295million was spent between 2016-2017 for herbal medicine and related products alone.

The endorsement of WHO for TCM is not universally welcomed by western doctors and scientists, but hopefully a standardized document can improve knowledge about its effectiveness. If TCM treatments are equally effective and dramatically cheaper, this could benefit people in poverty. On the other hand, if TCM is untested or dangerous, snake oil salesmen just got a green light from the WHO to expand their market.

(David Cyranoski, Nature)

Public Safety

Hurricane Florence is gone, water is contaminated, and scientists are looking for improvements in water testing

Hurricane Florence dumped billions of gallons of rain onto the south eastern US. Floodwaters are making their way to the coast; taking with them contaminants from agriculture and industry – effectively bringing hazardous drinking water to all who are downstream. Agricultural hazards include lagoons of livestock waste or enclosures full of dead chickens and hogs. Industrial hazards like coal ash in ponds and petroleum plant waste have also been affected, bringing hazardous bacteria and pollutants into municipal water supplies and the 9,000,000 private wells.

As towns, farms, and factories attempt to pump flood waters out of their locations, downstream and coastal water become contaminated. During times like these, the U.S. Environmental Protection Agency (EPA) sends On-Scene Coordinators to State Emergency Operation Centers to assist responses to hazardous substance environmental exposures. This requires testing drinking water systems for contaminants; last week 23 drinking water stations in North Carolina had halted operations, while another 21 were operating with boil water advisories.

The way water is currently tested for microbial contaminants requires a multiple day delay before results are obtained because they require bacteria to be grown in an incubator. A microbiologist at the University of North Carolina in Chapel Hill, Rachel Noble, is developing new ways to test for contaminants with a significantly shorter delay for results. Her group is testing water directly for DNA related to pathogenic bacteria like E. coli, or salmonella or viruses like Norovirus and adenovirus. Testing for DNA cuts the time from 1-2 days to 2 hours or less. Although her tests are conclusive, getting federal agency approval for test efficacy may take more time. Once contaminants are detected, water treatment facilities usually decontaminate by letting chlorine sit in the system for 24 hours. Dr. Noble emphasizes that there are other contaminants, notably pathogens from hog farms or industrial waste, that are not well understood, and this strategy may not be effective.

For the next hurricane, improvements to industrial and agricultural waste processing could reduce the risk of exposure, but there are no (monetary) incentives to do so. However, improvements to testing water safety are now being improved by scientists like Dr. Noble.

(Jennifer Allen, Kirk Ross, and Mark Hibbs, North Carolina Health News;

Frankie Schembri, Science)

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September 28, 2018 at 6:12 pm

Science Policy Around the Web – September 21, 2018

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By: Mohor Sengupta, Ph.D

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Inclusion in healthcare

India’s Anti-Gay Law Is History. Next Challenge: Treat LGBTQ Patients With Respect

On September 6 this year, in a landmark verdict, the Supreme Court of India officially decriminalized gay sex. It was a much-awaited move that toppled the archaic, colonial-era Section 377 of the Indian Penal Code, which was used to criminalize sexual activities “against the order of nature”. In 2009 Section 377 was provisionally invalidated, prompting more Indians to come out. But in 2013, the law was reinstated, as it was “a miniscule fraction” of the population that was in question. Although the country has made a decisive and progressive leap catapulting itself into the international arena of contemporary sexual norms, a big change is still needed in its healthcare sector to accommodate the repeal.

Till this date, reporting to clinics or hospitals is an ordeal for the LGBTQ community. Routine prescriptions like the preventive post-exposure prophylaxis for homosexual men is still met with confusion and dilemma at the clinic. Situations have changed from the time when HIV infection was a social stigma, but it isn’t quite at a place where a transgender or homosexual person can talk freely about their medical problems with healthcare personnel. Many doctors view different sexual orientations as something that can be “cured”. Such attitudes have caused a large section of the LGBTQ community to avoid seeing a doctor altogether. Most visit clinics recommended by others in the community.

In April 2014, the Supreme Court of India officially recognized the transgender community as a third gender and granted them the same fundamental rights that the Indian Constitution grants all citizens. Gender-reassignment surgeries were legalized. Yet, in most government hospitals, patients are segregated into a male or a female ward. Arnav Srinivasan, a transgender person and almost approaching menopause, has never visited a gynecologist even though it is necessary. Government directive to construct more gender-neutral public toilets hasn’t seen the light of the day.

Indians and people all over the world are rejoicing the recent Supreme Court repeal of IPC Section 377, and rightfully so. But now the major problem grappling the government is how to educate healthcare personnel about LGBTQ-specific health issues and disseminate appropriate instructions to law enforcement agencies, where harassment of LGBTQ people has been common. The Supreme Court did mandate sensitization programs for schools and the police and some non-profit organizations are planning to offer anti-discrimination workshops to district courts and law enforcement agencies.

In an ethnically, financially, and educationally diverse and sometimes disjointed community like India, repeal of IPC Section 377 is only the tip of the iceberg. It has heralded a new age of public health policy. Attitudes towards sexuality and sexual health needs a systematic and major re-orientation.

(Sushmita Pathak & Furkan Latif Khan, NPR)

Climate

Florence, Mangkhut bring data and destruction to coastal scientists

Two violent weather systems rocked two opposite ends of the world recently. Hurricane Florence originated from a strong tropical wave off the African west coast and it steadily intensified into a Category-4 hurricane en route to North America. Subsequently weakened, it made landfall just south of Wrightsville Beach, NC on September 14. Typhoon Mangkhut arose from a tropical depression near the International Dateline and rapidly intensified in strength as it moved westwards. It made landfall as a Category-5 equivalent super typhoon in the Cagayan province of Philippines on September 15. Both storms have caused significant damage to life and property, mostly in USA, Philippines and Hong Kong.

Meteorologists in USA have noted that recent tropical storms here have caused more floods than damaging winds. They attributed this observation to rising atmospheric temperatures, which make these storms hold on to greater amount of moisture. Overall warmer weather also diminishes the temperature differences between land and ocean, making the storm hover on the land for longer durations. Although wind speeds were as high as 215 km/hr, it was sustained winds that drove large volumes of water on land and caused widespread flooding in affected areas.

Typhoon Mangkhut, on the other hand, brought damaging winds with gusts of up to 228 km/hr in Hong Kong. Tall buildings in the city caused wind tunneling, that shattered its walls. We are all familiar with photographs of skeletonized buildings left in the wake of the storm.

In all this havoc, weather scientists have gained valuable information about overtures of a changing climate pattern. Giant waves off the coast of Wilmington, NC, dragged out a buoy equipped with sensors that measure wind speeds, wave heights and other storm conditions. All data management and web services connected to these sensors had been migrated to Amazon cloud services and provided that the buoys remained functional through the storm, data collected from the sensors could be invaluable. Earlier this week it was still transmitting data and Debra Hernandez, executive director of the buoy’s operator, the Southeast Coastal Ocean Observing Regional Association in Charleston, SC is waiting to see if that data can be tapped. Two automated submarine gliders, also known as autonomous underwater vehicles (AUVs), equipped with sensors to detect water temperature, chlorophyll a, salinity etc, have been deployed along the American continental shelf. These could throw more light on specifics. Ocean researchers at The Swire Institute of Marine Science, The University of Hong Kong (HKU) are beginning to comb through the data collected on Mangkhut. They learned that the storm had passed over relatively cooler surface waters before it made landfall, and this took away some of its power.

Climate change is very real, and its tangible effects are already showing. At most we can brace ourselves from such extreme weather, but it is of utmost importance to gather as many facts as possible and get to “know” these storms, to brace ourselves better.

(Frankie Schembri, with reporting by Dennis Normile and Paul Voosen, Science)

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September 21, 2018 at 3:48 pm

Science Policy Around the Web – September 19, 2018

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By: Saurav Seshadri, Ph.D

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Clinical Trials

Universities are worse than drug companies at reporting clinical trial results

Reporting the methods and results of clinical trials, in a timely and accurate manner, is critical to the process of drug development.  Such reporting is described by the World Health Organization as a ‘scientific, ethical, and moral responsibility’.  However, a recent study conducted by Oxford University’s Evidence-Based Medicine (EBM) DataLab has found that less than half of clinical trials conducted in the EU since 2004 actually fulfilled this responsibility.  In fact, an abysmal 11% of trials with non-commercial sponsors had reported their results, with many institutions reporting results for 0% of up to 200 registered trials.  Industry sponsors did a better job, with almost 70% of trial results reported, and higher rates of reporting among companies with more trials.  Of equal concern, inaccurate reporting appeared to be rampant in the EU Clinical Trials Register database.  For example, 30% of trials that were listed as ‘completed’ or ‘terminated’ did not have an end date, and therefore couldn’t be evaluated for timeliness (results are due after 1 year).

Clinical trial data reporting is governed by a similar system in the US: sponsors are required by the FDA to post results on ClinicalTrials.gov within a year of completion.  But the problem of lax reporting is well known, and the current results are in line with previous reviews.  In February, the EBM DataLab launched a tool to monitor trial reporting, aiming to increase public accountability by ranking sponsors, tabulating potential fines, and regularly notifying the FDA of non-compliance.  Legally, investigators can be charged $11,569 per day for late reporting, and according to the tracker, unclaimed fines now add up to more than 650 million dollars.  The Oxford team recently launched a similar tool for the EU.

Many factors are likely to contribute to the problem of non-compliance in academia.  These include an absence of a ‘culture of reporting’, unfamiliarity with data curation or registration procedures, pressure to save data for a high-profile publication, and unwillingness to accept negative results.  In the end, effecting a change in academic reporting habits will require a combination of public scrutiny and institutional support.  The EBM DataLab has at least the first part well in hand.

(Tania Rabesandratana, Science)

Health insurance

Merger of Cigna and Express Scripts Gets Approval From Justice Dept.

In a recent announcement, the Department of Justice (DOJ) appears to have cleared the way for a more consolidated healthcare landscape.  After over a year of review, the DOJ has granted approval for the $52 billion merger between Cigna, a major health insurance company, and Express Scripts, a leading pharmacy benefits manager (PBM).  According to the companies, this union between the entities who pay for and provide prescription drugs will allow them to share patient information and eventually negotiate better drug pricing.  While the details are unclear, the DOJ apparently agrees on the principle; a separate merger between Aetna and CVS Health, valued at $69 billion, is now expected to be greenlit as well.

The decision represents a path forward for insurers, whose previous attempts to merge with each other were blocked by federal antitrust officials.  Overall, the shift towards vertical integration is largely a response to Amazon, which caused many health companies’ stocks to plummet when it revealed its intention to enter the healthcare industry earlier this year.  Amazon’s partnership with investment titans Berkshire Hathaway and JPMorgan Chase & Co, as well as its purchase of online pharmacy Pillpack.com, make it a credible threat even to well-established companies in the notoriously complicated healthcare industry.  Until recently, the Cigna-Express Scripts deal itself was vehemently opposed by activist investor Carl Icahn, who urged shareholders to vote against it on the grounds that competition from Amazon would soon render the PBM model inviable.

The mergers may also be an attempt by established companies to show that they are trying to adapt their business models to address growing public dissatisfaction with drug pricing and access.  However, there is no guarantee that any discounts that these more powerful, merged organizations are able to obtain will be passed on to customers.  Critics ranging from the pharmaceutical lobby to the Trump administration have suggested that PBMs are designed to maximize profit rather than help patients.  On the other hand, the merger may increase competition among insurers (and thereby benefit patients) by enabling Cigna to enter new markets.  With Amazon closing in, healthcare companies’ survival may ultimately depend on their ability to balance putting themselves or their customers first.

(Reed Abelson, The New York Times)

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September 19, 2018 at 11:35 am

Science Policy Around the Web – September 11, 2018

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By: Liu-Ya Tang, Ph.D

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New Therapies

Here’s what we know about CRISPR safety – and reports of ‘genome vandalism’

Since its discovery in 2012, CRISPR-Cas9 has become a popular gene-editing tool forr removing, adding or altering sections of the DNA sequence in the genome. It has been widely used in research settings because it is efficient, precise and cheap. Beyond that, there is a growing interest in applying CRISPR techniques in treating human diseases which are caused by genetic mutations. Firms such as CRISPR Therapeutics, Intellia Therapeutics and Editas Medicine are conducting clinical trials of therapies using CRISPR. For example, one of the pipelines from CRISPR Therapeutics is a gene-editing Phase I/II trial for beta-thalassemia and sickle cell disease, which are caused by mutations in β-globin gene. Hematopoietic blood cells, which are the stem cells that generate red blood cells, are taken from the patient. After genetic correction, the cells are then reintroduced to the same patient. The hope is that the “revised” stem cells will produce normal red blood cells, which will cure the disease, relieving the patients from a lifetime of blood transfusions. Furthermore, there are other clinical trials of treatments for Hemophilia, Duchenne muscular dystrophy and cystic fibrosis by CRISPR. In China the technology has been used to treat patients with oesophagus cancer.

Though there is great potential for applying CRISPR to cure human diseases caused by various genetic mutations, cautionary measures need to be implemented while the safety of this technology is being debated. Several studies have raised concerns that CRISPR may not be as effective as previously thought, and in some cases it may produce unwanted side effects. The data have shown that applying CRISPR-Cas9 system on human body may cause stress to cells and some people may not be responsive to CRISPR-based therapy if their immune system has developed an immune defense against the CRISPR protein. Additionally, studies show that CRISPR-Cas9 may cause off-target DNA damage during genome editing, and the rate is about 1 to 5 percent. However, the clinical application of CRISPR editing is a work in progress. Hopefully new versions of the technique with improved accuracy and efficiency will be used to treat genetic diseases in the near future.

(Jianhua Luo, The Conversation)

Public health

Hospitals are fed up with drug companies, so they’re starting their own

Shortages of critical generic drugs and price spikes on old drugs have plagued hospitals in recent years. To resolve this, a group of major American hospitals are launching a nonprofit and independent generic drug company, which is called Civica Rx.

The company’s mission is to “make sure essential generic medicines are affordable and available to everyone”, so it will focus initially on establishing price transparency and stable supplies for 14 generic drugs used in hospitals. Civica is backed by seven large health systems and three philanthropic groups including Mayo Clinic and HCA Healthcare, collectively representing about 500 hospitals. A commitment of $100 million from governing members have been contributed to the effort, and member health care organizations have agreed to buy drugs from Civica based on the long-term contracts.

The list of 14 drugs haven’t been disclosed because of competitive reasons, but they include generic drugs that underwent price increases of 50 percent or more between 2014 and 2016 and essential medicines that were on national shortage lists. It is estimated that the first drug from Civica could hit the market next year.

The establishment of Civica would present a “threat” to other pharmaceutical companies that make the same generic drugs. There is a possibility that those companies will temporarily cut their prices to maintain the market share. But Civica leaders say the model of guaranteeing a steady supply at a fair, transparent price will be attractive to hospitals. Martin VanTrieste, chief executive of Civica, hopes that the entrance of 14 generic drugs to the market is a good correction for the over-priced drug market and the company would expand if the market place cannot be fixed by adding these 14 drugs.

(Carolyn Y. Johnson, The Washington Post)

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September 12, 2018 at 8:56 am