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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

Science Policy Around the Web – August 31, 2018

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By: Jennifer Patterson-West, Ph.D

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source: defense.gov

Public Health

Record High Number of STD Infections in U.S., As Prevention Funding Declines 

This week at the biennial 2018 National STD Prevention Conference sexual health professionals, including scientists and clinician, discussed new prospects to improve the health of our communities at a time when STD rates are on the rise.

The United States has the highest rate of sexually transmitted diseases (STD) in the industrial world.  Preliminary data indicates that nearly 2.3 million cases of chlamydia, gonorrhea, and syphilis were diagnosed in 2017.  These numbers reflect an increase in gonorrhea cases by 67% and syphilis by 76% over the past 4 years.

The director of the Center of Disease Control (CDC)’s division of STD prevention, Dr. Gail Bolan warns that “we’ve been sliding backwards” in our efforts to control STDs.  A major challenge in mitigating the spread of STDs is that the majority of individuals that carry the disease display no symptoms and remain unaware that they are infected.  For this reason, annual testing for chlamydia and gonorrhea is recommended for sexually active women under the age of 25 and males with male partners.  Patients are strongly encouraged to request STD testing because not all doctors will habitually offer these tests.

David Harvey, executive director of the National Coalition of STD directors, notes that congenital transmission of syphilis is diagnosed in a thousand babies annually despite the virtual eradication of HIV transmission from mother to child.   The continued occurrence of congenital syphilis, which can cause birth defects or result in stillbirth, is shocking due to the fact that syphilis can be effectively treated by antibiotics if caught early.

David Harvey emphasizes that a key factor in this growing health crisis is a roughly 40 percent drop in funding for the prevention and control of STDs over the past 15 years.  Taking into account that more than 50 percent of all Americans will contract an STD in their lifetime, the prevalence of STDs in the U.S. is a health crisis that needs to be addressed before our current methods of treatment are no longer effective. For instance, 4 percent of Neisseria gonorrhoeae patient samples are now resistant to antibiotic treatment. This Illustrates the need for new treatment options and the increased engagement with the public to encourage testing and the use of preventative measures.

(Richard Harris, NPR)

The Environment

Will More Logging Save Western Forests from Wildfires? 

According to the National Interagency Fire Center there have already been 38,832 wildfires this year.  Approximately 90 percent of these are human-caused due to negligence or intentional acts.

Given suitable environmental conditions, something as inane as the sparks from a flat tire has the potential to cause a catastrophe.  These circumstances are what caused the Carr Fire in Redding, California that burned over 200,000 and destroyed more than a thousand homes.

Recent disasters have people looking for preventative measures to minimize the occurrence and spread of wildfires.  In response, the Trump administration is promoting the expansion of logging in western states.  The administration emphasizes that environmental regulations are magnifying this issue.  Senator Steve Daines (R-Mont.) proposed a bill, Protect Collaboration for Healthier Forests Act, to accelerate forest management projects by reducing legal appeals.

However, forest and industrial experts counter that a sustainable solution is actually more involved and expensive then the simple expansion of logging.  Bill Oliver, a retired forest official, stresses that the forests are too dense and that bushes and small diameter trees that fuel mega fires are what need to be cleared. Conversely, it is the larger trees that are coveted by the timber industry and consumers.

However, one of California wood producer’s Sierra Pacific industry is investing in upgrading systems to use smaller diameter wood to produce commercial products, such as particle board. Dan Tomascheski, the vice president of Forest Resources for Sierra Pacific Industries, asserts that industry will need reassurances that use of public lands will not be a short-term initiative.

The Forest service affirms that nationwide there are approximately 80 million acres of forest lands at high risk of major fires with only two million have been treated thus far. Despite the potential benefit of forest management project, Forest management consultant Rich Armstrong emphasizes that budget cuts for wildfire mitigation and other forest programs are the biggest enemy to forest management. A separate fund to pay for wildfire suppression has recently been passed in congress due to bi-partisan efforts and will go into effect next year.

(Kirk Siegler, NPR)

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August 31, 2018 at 5:25 pm

Science Policy Around the Web – August 28, 2018

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By: Patrick Wright, Ph.D

Pills

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The Opioid Epidemic

Tapered to Zero: In Radical Move, Oregon’s Medicaid Program Weighs Cutting Off Chronic Pain Patients from Opioids

Oregon is considering legislation that would end insurance coverage of opioids for chronic pain patients enrolled in the state’s Medicaid program in an effort to battle the opioid abuse and overdoses. In 2016, 42,000 Americans died from drug overdoses involving opioids. As of 2016, Oregon’s overdose rate was roughly half the national average, with its prescriber rates slightly higher than the country’s as of 2015. Medicaid patient enrollees are prescribed opioids at a disproportionately high rate and are subsequently at a higher risk for overdose than the general public.

“We believe Oregonians in chronic pain deserve safe and effective pain management. And at the same time, we’re concerned about overdose and death, and we believe pain patients have been put at higher risk with regard to overprescribing.” said Dr. Dana Hargunani, Chief Medical Officer of the Oregon Health Authority (OHA). While other states have worked to improve their drug monitoring programs and have limited first-time opioid prescriptions for acute pain at 3,5, or 7 days, none have gone as far as to remove patients who have not exhibited signs of addiction or abuse. Unfortunately, there is currently not enough evidence on either side to know the most effective, safest approach to managing this issue; long-term opioid therapy has both benefits and risks.

The Centers for Disease Control and Prevention (CDC) states there is insufficient evidence to draw any conclusion. Its guidelines state that physicians must weigh managing the original pain symptoms warranting opioid treatment against the symptoms of withdrawal that will occur coincident with treatment cessation if the patient is opioid dependent. Specifically, it says: “Tapering plans should be individualized and should minimize symptoms of opioid withdrawal while maximizing pain treatment with nonpharmacologic therapies and nonopioid medications”. Beginning in 2020, opioid doses for Oregon’s Medicaid patient populations would be tapered to zero over 12 months under the new policy.

The proposed policy is not strictly black-and-white, however. “It is important to note that this policy would not be universal. If doctor/patient felt that the taper was inappropriate because of the specific circumstances and comorbidities for that patient, and exception could be requested and made by the plans,” noted an OHA spokeswoman. There are also disease-specific exclusion criteria, including cancer pain, sickle cell disease, and rheumatoid arthritis. Also, the proposal would include coverage for alternative, non-pharmacological therapies including acupuncture and chiropractic care, despite the evidence for the effectiveness of these approaches as opioid-surrogates being limited.

Many chronic pain patients and Medicaid enrollees in Oregon are protesting the proposal. Laura Dolph, a Medicaid enrollee in Oregon and chronic pain sufferer on an opiate regimen via her physicians, would be directly affected by this policy. Laura has suffered from chronic pain for decades due to porphyria and a back injury from a 1999 car crash. When she previously did not have access to legally prescribed opiates, she turned to illicit drugs. Her daughter, Heather Steinmann, said of her opiate use “When it’s been monitored, she’s been doing great” and her prior issues with illegal drug use were “all because her pain medications were cut off, and she went to street drugs. That’s how I view it. If you don’t have one, then you go to the other.” One of Laura’s previous physicians responsible for prescribing her opiates for pain management said “I was able to taper her down significantly on both [opiates and benzodiazepines] to minimize harm. But I felt like the greater harm would have been if I’d completely taken away her opiates without anything else to give her. I think she probably would have died.” There is also limited scientific evidence outlining the potential positive results of such a plan as a weapon against the opioid epidemic. “What is notably missing is any review of any literature regarding the centerpiece of their proposed policy: Forced opioid taper to zero for all persons” said Dr. Stefan Kertesz, a pain and addiction specialist at the University of Alabama, Birmingham.

Policies such as this proposed by Oregon are a response and consequence to years of over-prescription of opioids for pain management due to inaccurate portrayals of the potential harm of opioids early on. There is an ongoing federal case National Prescription Opiate Litigation (MDL 2804) in the United States District Court of the Northern District Ohio in which hundreds of cities and states are suing manufacturers and distributors, alleging that “manufacturers of prescription opioids grossly misrepresented the risks of long-term use of those drugs for persons with chronic pain, and distributors failed to properly monitor suspicious orders of those prescription drugs—all of which contributed to the current opioid epidemic”.

(Lev Facher, StatNews)

The Opioid Epidemic

In San Francisco, Opioid Addiction Treatment Offered on the Streets

This past May, Mayor Mark Farrell of San Francisco announced a plan to spend $6 million over the next two years on a first-in-the-nation public health program in which city health workers provide homeless people with opioid use disorder with buprenorphine prescriptions which they can fill the same day. This program is partly in response to the increase in the number of people injecting drugs in public spaces in the city. Most of the money will go toward funding 10 physicians as part of the Department of Public Health’s Street Medicine Team. Mayor Farrell emphasized, “The opioid crisis plaguing our country is alive and visible on the streets of San Francisco. The status quo is simply unacceptable. I am creating this program to directly address drug addiction on our streets—to meet these individuals where they are and get them the help they need, and to ensure that our streets remain safe for all our residents”.

This approach is to complement more conventional, clinic-based opioid treatment and outreach methods. A study by Amos Irwin and colleagues included a cost-benefit analysis of potential supervised injection facility (SIF) in San Francisco and found there would be a $2.33 in savings for each dollar spent on a SIF, providing a total annual net saving of $3.5 million for a single 13-booth SIF while reducing the number of total hospital stays and HIV and Hepatitis C cases. Nevertheless, offering these buprenorphine prescriptions in situ, on the streets rather than in a clinic, might help patients bypasses visiting clinics themselves and dealing with appointment scheduling and attendance. The people approached on the streets also tend to be longer-term users compared to those at needle exchange sites, which tend to skew younger and with a shorter history of using. Dr. Barry Zevin, the medical director for Street Medicine and Shelter Health in San Francisco noted, “These vulnerable and complex patients care about their health, but they have suffered from stigma that makes it difficult for them to access the health care system.”

Buprenorphine is the first medication to treat opioid dependency that is permitted for prescription and dispensation outside of a structured clinic. It is a partial opioid agonist approved for clinical use in October 2002 by the Food and Drug Administration. In its capacity as an agonist, it does produce opioid-analogous effects such as euphoria, but in weaker form than that of full opiates. Importantly, however, it helps to lower the potential for misuse, diminishes the effects of physical dependency to opioids such as withdrawal symptoms, and reduces the risk of overdose. It is a form of medication-assisted treatment (MAT) to help users of opiates to reduce or quit.

Thus far, at the end of a yearlong pilot that ended in November 2017, 20 of the 95 participants were still taking buprenorphine under the care of the street medicine team. With the $6 million investment, more than 250 patients will have access to buprenorphine. However, there are an estimated 22,500 active injection drug users in the city as of 2015, half of whom report using heroin. This program is one component of many in the city’s plan to combat the opioid crises. San Francisco Health Director Barbara Garcia stated “Homeless people who use drugs are especially vulnerable, and our system of care needs to adapt. By going directly to them with compassionate outreach and expertise, we are able to help a group that we were missing by relying on a more traditional structure of clinic visits that does not work for everyone.”

(Abby Goodnough, The New York Times)

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August 28, 2018 at 6:02 pm

Science Policy Around the Web – August 24, 2018

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By: Maryam Zaringhalam, PhD

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source: pixabay

Public Health

Doing time on drugs: Jails are slow to dispense meds that curb inmates’ cravings

According to a National Inmate Survey conducted between 2007 and 2009, one in five local jail and state prison inmates across the country have used heroin or opioids, in part because of criminalization of drug use and addiction. In 2010, about 2 million adults were incarcerated in local jails and state prisons. A population of about 400,000 inmates could stand to benefit from opioid interventions. However, only 220 of 3,000 jails nationwide offer naltrexone — a drug that blocks the effects of opioids and can reduce cravings — to inmates. And only about 20 jails offer methadone or buprenorphine — drugs that diminish withdrawal symptoms and reduce cravings.

These medications have been found to increase the likelihood that a person will remain in treatment for drug addiction, which is associated with reduced risk of criminal activities and greater likelihood of employment. Treatment of inmates can also reduce the number of overdose deaths within inmate populations, as well as among people released from jail or prison. Rhode Island has adopted a new program offering its prisoners medication to treat opioid-use disorders. Last year, the number of overdose deaths across Rhode Island plunged by 61 percent among people newly released from jail or prison. In addition, medication can stave off the effects of withdrawal, which is particularly beneficial for opioid users who are newly incarcerated and are forced to quit use cold turkey.

Despite the benefits of medication-assisted treatment, it hasn’t been widely adopted and access remains limited within the criminal justice system. A long-standing belief prevails that abstinence is the cure to overcoming addiction. As a result, medications are stigmatized as a treatment option, despite the body of evidence that points to their efficacy. Methadone and buprenorphine are themselves opioids, though they do not produce the euphoric highs when taken as prescribed, which further reinforces the stigma. In addition, because misuse of these drugs can cause mild opioid-like effects, misuse and illicit sales in jail and prison remains a concern.

Nevertheless, a number of stakeholders in the medical and criminal justice communities, including the American Medical Association, the American Society of Addiction Medicine, and the American Correctional Association, have released statements supporting the use of medications in jail and prison populations.

(Anna Gorman, The Washington Post)

U.S. Policy

Here are 10 topics senators could ask Trump’s science adviser nominee to address

Earlier this month, President Trump nominated meteorologist Kelvin Droegemeier to serve as director of the Office of Science and Technology Policy (OSTP) and act as science adviser to the President. Droegemeier appeared before the Senate on Thursday to begin his confirmation process, which stands to end the longest vacancy in the 42-year history of the OSTP. A well-respected, extreme-weather scientist, Droegemeier stepped down from his post as vice president for research and emeritus professor of meteorology at The University of Oklahoma. His nomination has been largely praised by the scientific community and previously served as vice-chair of the governing board of the U.S. National Science Foundation.

During his confirmation hearing, he is likely to receive questions ranging from concerns around deepening budget cuts to agencies that fund scientific research to concerns around the place of scientific evidence in federal decision making. His position on the role of human activity in climate change will likely also be called into question, particularly in light of comments he made in a 2014 talk at the South Central Climate Center in which he said: “The evidence suggests that [climate change] is human-induced, that is, there’s a strong human signal. But we don’t know everything about the nitrogen cycle, about all the carbon cycling, and about carbon sequestration … I’m very skeptical of people who take that almost deeply ideological position and say we absolutely know the answer. No, we don’t.” He may also face questions regarding the growing movement around combating sexual harassment in STEM fields and the impact of restricting entry of foreign students on research progress in the United States.

OSTP is charged with coordinating federal science policy throughout the executive branch and providing scientific and technological analysis and judgment for the President. Given his track record, Droegemeier is likely to pass through confirmation. Former OSTP Director John Holdren told Science: “I expect he’ll be energetic in defending the R&D budget and climate change research in particular.”

(Jeffrey Mervis, Science)

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August 24, 2018 at 5:55 pm

Science Policy Around the Web – August 16, 2018

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By: Sarah Hawes, Ph.D.

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Scientific Discoveries

Ambitious ‘Human Cell Atlas’ Aims To Catalog Every Type Of Cell In The Body

You’ve no doubt heard of the Human Genome Project – a 15-year long endeavor to sequence the total human genome, fueled by 3 billion dollars and completed in 2003. But have you heard of the Human Cell Atlas Consortium? MIT biology professor and member of the Broad Institute Aviv Regev has led this collective of hundreds of international scientists since its foundation in 2016.

Just as the intent of the Human Genome Project was to sequence all our genetic material, the intent of the Consortium is to identify every single type of cell in the human body so that they can be investigated and understood independently, and in the complex context of cell-cell interactions, and their role in our physiology. This is a huge endeavor. We currently lack even a rough estimate of how many cell types exist. “People guess anything from the thousands to the tens of thousands. I’m not guessing,” Regev says. “I would rather actually get the measurements done and have a precise answer.”

And how does one delineate cell types in a meaningful way, to take these measurements? This is done by determining which genetic material a cell activates, i.e. which genes it mobilizes from quietly bundled DNA to RNA, and from there into a meaningful protein product to carry out the particular cellular functions defining a heart cell, or a lung cell, or a glial cell in the brain. The technology enabling description of a cells’ genetic character is called single-cell RNA sequencing.

In 2014, Aviv Regev, together with Steve McCarrol, and David Weitz at Harvard, improved on this process to substantially speed it up. “All of a sudden, we moved from something that was very laborious and we could do maybe a few dozen or a few hundred, to something where we could do many, many thousands in a 15- to 20-minute experiment,” Regev says. “We said, ‘That’s at the right scale that we could actually do the human body.’ And this is what they have set out to do.

Today, after just two years and 200 million in NIH funding, the Human Cell Atlas Consortium is beginning to bear fruit.

The first major Human Cell Atlas finding was published this month and simultaneously confirmed by a separate lab at Harvard Medical School. Both papers are published in the journal Nature, and report the definition of a new cell type in the windpipe which is responsible for creating a faulty protein linked to cystic fibrosis. Previously it was believed that the faulty protein originated in common cells lining the windpipe. Discovery of the new and rarer cells, dubbed ‘pulmonary ionocytes,’ will improve scientists’ ability to target faulty protein production by targeting the pulmonary ionocytes, thereby speeding up the development of treatments for cystic fibrosis.

A second consortium-related discovery appeared last week in the journal Science, in which British consortium members published the finding that childhood kidney cancer begins in a cell type which is distinct from the cells giving rise to kidney cancer in adults.

“We knew the lessons from the Human Genome Project were [that] rallying together the entire community would really let you get a full answer to a question. And that full answer will empower everyone to do better and faster and higher-resolution biology,” says Regev. Together, cataloguing all human cell types is predicted to take just another five to ten years. Discoveries building off this catalogue will dramatically enhance medical progress globally, and in perpetuity.

(Karen Weintraub, NPR)

Science and Innovation

It’s ‘Shark Tank’ For Global Health Inventions

A fascinating program to bolster innovation in global health, and particularly for impoverished mothers and children, is coming from a union between government agencies in the US, Norway, Korea, and the UK together with the Bill & Melinda Gates Foundation. This program, called Saving Lives At Birth: A Grand Challenge For Development, hosted a special conference in Washington, D.C. last week to empower global health inventors with the gift of pitch.

Nearly 500 applicants were winnowed down to ten participants, each of which presented global health innovations before a panel of judges rating them not on their science, but on their business plan – including target market, competition and revenue model.

Prior to presenting, each participant worked with consultants to enhance their slides and speeches. Rachele Haber-Thomson, one of the consultants, explained that many participants came from academia or non-profits. She said that while they knew how to write a grant, they needed help to capture the attention of investors looking for compact, business-savvy strategies.

Presentations were compact, seven-minute pitches on practical advances – describing a health problem, a solution, and convincing details on its implementation – all before taking questions from judges on feasibility, marketing, etc. The advances presented included an oxygen concentrator powered by running water, a medicine pouch to prevent transmission of HIV from mother to infant, a new subcutaneous contraceptive, and a system to generate disinfectant from salt and water. The winning pitch came from Gradian Health Systems, and was for a network of mobile medical training centers to enhance quality of care in areas with few physicians.

The prize for a winning pitch was not funding (though the audience included potential backers). Each participant had already been awarded $250,000 to $2 million from Saving Lives At Birth to develop their ideas prior to the conference. Instead of direct funding, the winner was given a choice between competing in a similar sales-pitch show-down in Berlin or else receiving free business-consulting.

As Sofia Stafford of USAID and Saving Lives At Birth puts it, “if these global health projects want to scale up, they need to know how to communicate their vision, grab investors’ interest and attract more funds.” Bearing this in mind, the July conference invokes the proverb “give a man a fish and he’ll eat for a day; teach a man to fish and he’ll eat for a lifetime.” Saving Lives At Birth does both.

(Vicky Hallett, NPR)

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Written by sciencepolicyforall

August 16, 2018 at 4:31 pm