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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 – April 13, 2018

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By: Maryam Zaringhalam, Ph.D.

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Public Health

Flint school children to be screened for effects of lead after agreement

April 25th will mark four years since Flint, Michigan had clean drinking water. In that time, the water has been contaminated with lead at levels above hazardous waste and with pathogens like Legionnaires’, which resulted in an outbreak that left 12 dead. The mishandling of Flint’s water crisis has resulted in a number of lawsuits and several felony convictions, with charges ranging from conspiracy to involuntary manslaughter.

Most recently, a judge approved a $4 million legal agreement on Thursday to screen children for exposure to lead poisoning and evaluate their cognitive development, memory, and learning. The lawsuit was first filed in 2016 by a coalition of local and national groups sued the Michigan Department of Education and school districts in Flint. Exposure to lead — a neurotoxin — during childhood can have long-term adverse health effects on cognitive and physical development. As a result, children exposed to lead may require special education services. The results of these evaluations, which will begin in September, will be used to better provide services to the children affected by lead exposure. Dr. Mona Hanna-Attisha, director of the Michigan State University-Hurley Children’s Hospital Pediatric Health Initiative and an early advocate for the Flint community, will oversee the program. The lawsuit will continue in Michigan federal court to increase special education services and reforms with representation by the ACLU of Michigan.

The Flint water crisis began in 2014 when the city switched its water supply from Lake Huron to the Flint River, which had long been polluted by industrial byproducts. Flint residents immediately reported poor-tasting water, however, their complaints were ignored by government officials despite robust community advocacy efforts. Finally, in September 2015 scientists at Virginia Tech published an extensive report (made possible by collaboration with members of the Flint community) documenting dangerous levels of lead in Flint residences, followed by a report from the Environmental Protection Agency (EPA). Pollution in the river had created a fertile breeding ground for bacteria, so the river was treated with chlorine, making the water acidic, in turn leaching lead from Flint residents’ plumbing. The crisis could have been prevented if appropriate corrosion control measures were taken.

On April 6, Michigan Governor Rick Snyder announced Flint’s water is once again safe for drinking, terminating the free bottled water program designed to give Flint residents safe water as part of a $450 million state and federal aid package. Nevertheless, mistrust remains.

(Alex Dobuzinskis, Reuters)

Healthcare

Trump administration rewrites ACA insurance rules to give more power to states

After several unsuccessful Congressional attempts to repeal the Affordable Care Act (ACA) last year, the Trump administration has taken steps to roll back ACA regulations with 523 pages worth of new and revised rules. The new regulations will take effect for ACA health plans sold this fall for 2019 coverage.

Perhaps the most significant change comes from a new rule aimed at shrinking the authority of the individual mandate — the ACA provision that every individual must have healthcare or face a penalty. Individuals can seek exemption from that requirement through one of two broad channels. On Monday, April 9, the Centers for Medicare & Medicaid Services issued a final notice that individuals living in counties with only one or no ACA insurers qualify for a “hardship exemption” because the marketplace is not competitive in their region. Notably, in 2018, around half of US counties had only one or ACA insurers. Individuals opposing abortion can also qualify for exemption if their only ACA provider options cover abortion. In November, the Congressional Budget Office projected that a straight repeal of the individual mandate would increase premiums by ten percent; so even a partial effective repeal could lead to increased premiums for customers opting to stay on ACA plans.

The new rules also grant states much more authority and flexibility when determining whether healthcare plans meet ACA standards. The old ACA rules required insurers provide a standard set of ten essential health benefits to ensure customers had access to the same core set of benefits and allow them to comparison shop. Before, states were required to base these ten categories on the same benchmark plan within state borders. The rule has now been changed so that states can select different benchmark standards across state lines a la carte (i.e. a maternity care standard from New Jersey paired with a laboratory services standard from Arkansas).

CMS Administrator Seema Verma told reporters: “Ultimately the law needs congressional action to repeal.” But in the meantime, the above examples are only two of several changes that will reign in the ACA’s powers.

(Amy Goldstein, The Washington Post)

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April 13, 2018 at 4:02 pm

How do healthcare and health outcomes in the US compare to those of other developed countries?

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By: Vanessa Gordon-Dseagu, PhD

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For much of 2017, the Trump administration engaged in numerous attempts to repeal the Affordable Care Act – legislation that was considered by many to be the first step towards the introduction of universal healthcare within the US. As the debate continues over the role of the government in the provision of healthcare, comparisons with systems abroad may reveal important shortcomings within those found in the US. There are a number of methods to assess and compare the performance of a healthcare system; this essay focuses upon the key areas set out by the Peterson-Kaiser Health System Tracker – spending and health outcomes (those amenable to health-service provision) as well as the uninsured/access. By looking at the provision of healthcare internationally, we may learn key lessons in how to improve the US system.

Cost

In 2016 the US spent around 17% of its GDP on healthcare (around $3 trillion). This is almost double the amount spent by other industrialized nations, while the amount of healthcare used per capita is similar across countries. The key reason for this appears to be cost. Patients in the US pay far more for their healthcare to be provided than their international counterparts, with one study finding hospital prices in the US to be 60% more than those in Europe. One reason for this appears to be the high cost of insurance administration within the US system caused by, oftentimes, fractured and duplicative provision. Hospitals must employ large departments to properly bill insurance companies and verify insurance coverage, costs that are passed on to the patient. In comparison, nationally or regionally organized systems, free at the point of need, do away with the need for insurance administration. The Affordable Care Act (ACA) sought to address some of the administrative waste and duplication found within US healthcare provision by employing economies of scale and streamlining the insurance procedure.

The cost of prescription drugs in the US is also an issue for concern for patients and policy-makers alike. The US spends more per capita on prescription drugs than other countries within the Organization for Economic Cooperation and Development (OECD). A 2016 JAMA study found that per capita spending on prescription drugs was $858 a year within the US, compared with $400 for 19 other industrialized countries. One factor likely influencing this is the more rapid uptake of new and, thus, more expensive prescription drugs within the US compared with other OECD countries. While an equally important factor is the price at which the drugs are sold in the US compared to other countries – drug prices in the US are substantially increased compared with other markets. The experience internationally is that policies, such as centralized pricing and universal healthcare, as well as other price controlling strategies, are effective at reducing drug costs. While the majority of developed countries enact some form of price regulation, within the US, the federal government is legally prohibited from negotiating drug prices for its widely administered Medicare program. Further to this, for each new drug the US Food and Drug Administration approves, it upholds a market exclusivity period, ranging from six months to twelve years, in which it will not approve a generic form of the same drug, limiting access to cheaper generic drugs. This, combined with US patent law protections, means that, on average, a brand-name drug manufacturer can expect their product to be on the market between 12-16 years before  the introduction of generic competitors. In comparison, across Europe 13 countries have policies which make generic drug substitution mandatory, 13 have voluntary protocols, with only five forbidding the practice.

The uninsured and access to healthcare

The World Health Organization considers universal health coverage to be a system within which 1) individuals can use the health services they need; 2) the care is of a sufficient quality to be effective; 3) individuals are not exposed to financial hardship caused by accessing the services. Of the 35 countries within the OECD, 32 have healthcare legislation that is in keeping with the WHO definition of universal healthcare. The US is now the only high-income country not to offer universal health insurance coverage.

Although the introduction of the ACA reduced the number of uninsured in the US from 44 million in 2013 to a low of 28 million in 2016, by the end of 2017 the number of uninsured had again risen by 1.3%, an estimated 3.2 million individuals. The causes of this increase may relate to the uncertainty surrounding the potential repeal of the ACA under the current administration, the repeal of the individual mandate within the Trump tax bill, the exit of several insurers from the ACA market and increasing health insurance costs.

The benefits of healthcare coverage upon health outcomes are well documented and relate to access to preventive, ambulatory, primary and secondary healthcare. Further to this, access to healthcare is particularly important for those with complex or ongoing chronic conditions. A review of the evidence related to health insurance coverage and health concluded:

“There remain many unanswered questions about U.S. health insurance policy, including how to best structure coverage to maximize health and value and how much public spending we want to devote to subsidizing coverage for people who cannot afford it. But whether enrollees benefit from that coverage is not one of the unanswered questions. Insurance coverage increases access to care and improves a wide range of health outcomes. Arguing that health insurance coverage doesn’t improve health is simply inconsistent with the evidence.”

To overcome some of these issues, members of the House of Representatives (with a parallel bill introduced in the Senate in 2017) have been developing the Expanded & Improved Medicare for All Act, colloquially known as ‘Medicare for all’. The bill seeks to take the role of government in healthcare one step further than the ACA and introduce:

“A system in which a single public or quasi-public agency organizes health care financing, but the delivery of care remains largely in private hands. Under a single-payer system, all residents of the U.S. would be covered for all medically necessary services, including doctor, hospital, preventive, long-term care, mental health, reproductive health care, dental, vision, prescription drug and medical supply costs”.

Health outcomes

In relation to access, the US system has been found to fall short, particularly in the areas of primary care, prevention and management of chronic conditions. In its comparison of healthcare systems, the Commonwealth Fund concluded that the US ranked last on access. The insufficiencies of these areas of care contribute to the lower life expectancy found within the US compared with the majority of OECD countries – in their 2016 report, the US was found to rank 26 out of the 35 OECD countries. The same investigation found that the US also fell below the OECD average in several more nuanced indicators of health (for example maternal and infant mortality). In the same study undertaken by the Commonwealth Fund, the US ranked last out of 11 comparable countries for healthcare outcomes. The report also found that the US had the highest rate of mortality considered amenable to the provision of care. Compared with the other 10 countries under investigation, the US performed better in areas such as in-hospital mortality following a cardiovascular disease related event and five-year survival for some cancers. The lack of easily available preventative services may also contribute to the high, and increasing, rates of non-communicable diseases such as diabetes, as well as other conditions such as overweight and obesity, for which the US has the highest rates within the OECD.

Despite the substantially increased costs of healthcare in the US compared with international counterparts, the population is not experiencing a corresponding improvement in health outcomes. International comparisons suggest that tighter regulation of costs, particularly those related to insurance administration and prescription drugs, may go some way to addressing this issue. The introduction of universal coverage is also likely to allay some of the deficiencies inherent to healthcare provision within the US. How the issue of the provision of healthcare is broached by this, and future, administrations will have a substantial impact upon the health of the nation.

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February 1, 2018 at 11:42 am

Science Policy Around the Web – August 15, 2017

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By: Liu-Ya Tang, PhD

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Public Health

Obesity and Depression, Entwined or Not?

It might seem that obesity and depression are not related since they are diseases from different parts of the body; however, health care practitioners have observed that these two diseases have a close relationship. The development of obesity and depression can be a vicious cycle, one favoring the other. Extra weight brings anxieties to obese people, which can cause poor self-image and social isolation. These are known contributors to depression. On the other hand, people experiencing depression tend to overeat and avoid exercising. According to the federal Centers for Disease Control and Prevention, about 43 percent of people with depression are obese, compared with 36.5 percent of the general population. People with obesity have a higher risk to develop depression, and vice versa, according to one 2010 study.

Both obesity and depression are chronic diseases that are hard to treat, placing a big burden on the health care system. Obesity rates in the United States are among the highest in the world. Obesity alone costs almost $150 billion per year in direct expenses, and this number is estimated to increase about $1.24 billion each year till the year 2030. The cost of treating depression is even higher, which is more than $200 billion every year. So it is urgent to find ways to treat both diseases more effectively if they are bidirecitonally comorbid.

When depression and obesity coincide, the combination of physical and mental health interventions becomes important, which has been supported by several studies. Researchers from the University of Texas-Southwestern found that patients’ depression were alleviated when they did weekly exercise sessions, which were prescribed by physicians. Another study from Duke University found that the rate of depression in obese women was decreased by 50 percent simply by helping them control their weight. The combinatorial treatment has been adopted. Dr. Sue McElroy, a psychiatrist in Mason, Ohio, screens patients for weight and BMI, and treats obesity and depression together. She tailors her prescription, as some antidepressants can cause weight gain. Her “self-taught” method was welcomed by her patients. However, this is not a general practice in treating patients with both symptoms. To benefit patients’ health and reduce cost for curing obesity and depression, the whole health care system needs a change.

(Shefali Luthra, Kaiser Health News)

 

The ACA

What do people and health-policy experts think about repealing the ACA?

Since March, the Trump administration has strived to repeal and replace the Affordable Care Act (ACA), but the Senate rejected this repeal, as 3 republican senators voted “no” last month. How do people feel about repealing the ACA? What do most people say the Trump administration should do after the Senate failed to repeal? There were two reports about it.

The first one was about a survey conducted Aug. 1-6 by the Kaiser Family Foundation, which capture the opinions of 1,211 adults. Their analysis found that a majority of people (78 percent) think that the government should make the ACA work better. Grouping this majority by Political Party ID, reveales 95 percent are Democrats, 80 percent re independents and 52 percent are Republicans. Even 51 percent of President Trump’s supporters think both parties should work together to improve the health law.

The second report said that a coalition of liberal and conservative health-policy leaders is making suggestions for how to strengthen the existing ACA law, aligned with a favorable view in the public. The nine group members are from think tanks, universities and advocacy groups, who can be influential in health-policy formation of the government. The coalition was founded when it appeared that the Republican-controlled Congress would pass a repeal of the ACA without a replacement plan. It took the group eight months to come up with a five-point set of principles. It says that the government should continue providing subsidies to insurers that extend plans to 7 million lower-income customers and strong incentives for Americans to carry health insurance. The latter will help the cost of expensive care be shared by a stable insurance pool with healthy customers. They also urge the government to bring health plans to about two dozen counties, which would be left providerless in the ACA marketplace for 2018. The group said they intend to present their idea to Republican and Democratic lawmakers. “We are trying to model bipartisanship so incremental steps can be taken,” said by Ron Pollack, chairman emeritus of the liberal consumer-health lobby Families USA.

To prevent the potential collapse of health insurance market, the Senate is planning a bipartisan hearing on health care in September. In the House, a group of around 40 Republicans and Democrats known as the Problem Solvers Caucus aims to making urgent fixes to the ACA law. On September 27th, insurers will sign contracts with the federal government over what insurance plans to sell on the marketplace for 2018, which pushes Congress to come up with a solution before then.

(Phil Galewitz, Kaiser Health News, and Amy Goldstein, The Washington Post)

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August 15, 2017 at 6:27 pm

Science Policy Around the Web – May 5, 2017

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By: Thaddeus Davenport, PhD

Healthcare Policy

House Passes Bill to Repeal and Replace the Affordable Care Act

Thomas Kaplan and Robert Pear reported for the New York Times yesterday that Republicans in the US House of Representatives voted to pass a bill that would undo a number of central elements of the Affordable Care Act. Only six weeks ago, House Republicans failed to gather enough support to even vote on the first version of this bill, which was predicted to eliminate insurance coverage for twenty-four million Americans over the next decade. Since that time, Republican lawmakers have modified the so-called American Health Care Act (AHCA) bill to appeal to the more conservative members of the House – including provisions that would limit federal support of the Medicaid program, allow states to opt out of requiring that insurance cover services like maternity and emergency care, and also enable states to apply for waivers that would let insurance companies charge higher premiums for some individuals with pre-existing conditions. Like the first version, the bill that passed the House on Thursday does away with the ‘individual mandate’, which imposes a tax on people who can afford to buy insurance but do not – an aspect of the Affordable Care Act that was relatively unpopular but critical to ensure sustainability of the insurance markets. It also replaces government-subsidized insurance plans with tax credits between $2,000 and $4,000, depending on age. Other provisions in the bill would stop federal funding to Planned Parenthood for one year as well as eliminate taxes on high-income individuals, insurance companies, and pharmaceutical companies that helped to fund the Affordable Care Act. Yesterday, 217 Republicans voted in favor of the revised AHCA bill that will certainly  not provide healthcare insurance for everyone, without waiting for a non-partisan Congressional Budget Office analysis of the bill’s impact on the federal deficit or on the American people. These representatives’ haste reveals that they care little about how the AHCA will actually affect their constituents’ lives, and Democrats are counting on voters remembering this in upcoming elections. (Thomas Kaplan and Robert Pear, The New York Times)

Science Funding

NIH Funding Changes to Support More Early Career Investigators

The NIH budget has gradually declined over the last fourteen years, from $40 billion in 2003 to about $32 billion in 2017. Given that a proposed budget from the Trump administration for fiscal year 2018 would further cut funding for NIH by $5.8 billion, it is unlikely that funding for the NIH will increase dramatically in the coming years. To address these budget limitations, and in an attempt to do more with less, Jocelyn Kaiser reported for ScienceInsider this week that the National Institutes of Health will impose a cap on the number of grants awarded to investigators. In an open letter announcing the decision, NIH director, Francis Collins, writes that 40% of NIH funding is concentrated in the hands of 10% of NIH-funded investigators. He notes that this is not inherently problematic, except that many studies indicate that there are diminishing scientific returns on each additional dollar that is granted to any individual investigator. Under the new guidelines, investigators will be limited to a maximum of three R01-equivalent grants in order to support approximately 1,600 more grants to early career and mid-level researchers, who have been particularly affected by the declining NIH budget. While it is difficult to quantify scientific impact, the NIH decision is admirable for its intent to support diversity and efficiency in funding research. (Jocelyn Kaiser, ScienceInsider)

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Science Policy Around the Web – March 14, 2017

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By: Liz Spehalski, PhD

Affordable Care Act

ACA Replacement Bill Released by House

Last Monday, House Republicans released their plan to repeal and replace former President Obama’s Patient Protection and Affordable Care Act (ACA), also known as Obamacare. The American Health Care Act (AHCA), a more conservative vision for the nation’s health care system, was created as a collaboration between the White House and the Senate Republicans. The Republican Party has been critical of the ACA because of the large role that it created for the federal government in health care, such as the need for the IRS to verify eligible people for financial help and federally mandating the public to have health insurance.

The AHCA will maintain some of the popular features of the ACA, such as allowing young adults to stay on their parent’s health care plans until the age of 26, banning lifetime coverage caps, and maintaining the ban on discrimination against people with pre-existing conditions. It also temporarily maintains the expansion of Medicaid to cover millions of low income Americans through January 1, 2020.

Instead of the individual mandate, a fine penalizing Americans for failing to have health insurance, the new bill would try to encourage people to sustain coverage by allowing insurers to impose a 30 % fine to those who have a gap between plans. The AHCA also changes the structure of tax credits given to those who want to buy insurance. Under the ACA, people who earn less than 200 percent of the poverty line get the highest subsidies. The Republican plan would instead give tax credits based mostly on age. The AHCA will also cut off federal funds to Planned Parenthood through Medicaid and other government programs for one year.

While Republicans did not offer any estimate of how much their plan would cost, or how many people would gain or lose insurance coverage, the Congressional Budget Office released its estimate yesterday, raising concerns. Two key House committees swiftly approved the bill, but uncertainty surrounds how this bill will fare in Congress, as some conservatives are concerned that it does not go far enough to remove government from health care, while others are concerned about their constituents losing coverage due to the loss of Medicaid expansion. No Democrats are expected to support the bill. (

Obesity

Fewer Overweight Americans Trying to Lose Weight

A study published in the Journal of the American Medical Association this week found that the percentage of Americans trying to lose weight is declining. In 1990, when researchers asked overweight Americans if they were trying to lose weight, 56% responded yes, while that number decreased to 49% in 2014. Researchers analyzed US government health surveys from 1988 through 2014 which involved in-person physical exams and health- related questions including whether the participants had tried to lose weight within the last year. The study included over 27,000 adults ages 20-59, and weight status was determined using body mass index (BMI).

The explanation behind this trend seems to be the shift in public perception over dieting and overweight people. “Socially accepted normal body weight is shifting toward heavier weight. As more people around us are getting heavier, we simply believe we are fine, and no need to do anything with it,” said lead author Dr. Jian Zhang, a public health researcher at Georgia Southern University. The authors of the study also discuss other possible reasons for this data, such as primary care physicians not discussing weight issues with their patients.

Though the decline of 7% may seem low, this number could represent up to seven million Americans, as more than two thirds of adults are considered to be overweight or obese, according to recent NIH statistics. Scientists say this is concerning because obesity increases the risk of a host of diseases such as heart disease, diabetes, cancer, liver disease, osteoarthritis, and stroke. However, “There’s a possible good news story in this,” says Janet Tomiyama, a psychologist at UCLA who studies eating behavior and weight stigma. “We’re not going to shame people into health,” Tomiyama says, “a lot of research shows that having a healthy body image is what leads to better health outcomes. Maybe people are taking the focus off the number on the scale, and going more towards focusing on their health.” The CDC’s current  obesity prevention efforts focus on policy and environmental strategies that target the affordability of healthy eating and active living, noting that fad diets can be unhealthy and tend to fail over the long term. (Allison Aubrey, NPR)

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March 14, 2017 at 10:00 am

Science Policy Around the Web – July 26, 2016

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By: Ian McWilliams, Ph.D.

photo credit: Newport Geographic via photopin cc

Infectious Diseases

Research charities help marry two major South African HIV/TB institutes

Two institutes, the Wellcome Trust and the Howard Hughes Medical Institute (HHMI), have announced that they are joining efforts in to fund the fight against HIV and Tuberculosis (TB) in South Africa. South Africa has the largest population infected with HIV. Because TB thrives in HIV-infected individuals, South Africa is experiencing a co-epidemic that has been challenging to battle. This collaboration will mark the first time that HHMI and The Wellcome Trust have worked together on a global health institution.

The new Africa Health Research Institute combines the Africa Centre for Population Health’s detailed population data gathered from over 100,000 participants with basic laboratory science and medical research of the KwaZulu-Natal Research Institute TB-HIV (K-RITH). Together the organization will work towards eliminating HIV and TB by training African scientists and will “link clinical and laboratory-based studies with social science, health systems research and population studies to make fundamental discoveries about these killer diseases, as well as demonstrating how best to reduce morbidity and mortality.” Projects funded by the institute include maintaining the longest running population-based HIV treatment as prevention (TasP) trial in Africa and using genomics to study drug resistant TB.

The organization is funded by a $50 million grant from The Wellcome Trust that is renewable over the next five years. Additionally, HHMI has already spent $40 million for the construction of new facilities, including a new biosafety level 3 laboratory that is designed to handle dangerous pathogens. These new efforts aim to apply scientific breakthroughs to directly help the local community. Deenan Pillay, the director of the new institute, has expressed his support of the organization’s mission by stating “There’s been increasing pressure and need for the Africa Centre not just to observe the epidemic but to do something about it. How long can you be producing bloody maps?” (Jon Cohen, ScienceInsider)

Scientific Reproducibility

Dutch agency launches first grants programme dedicate to replication

While a reproducibility crisis is on the minds of many scientists, the Netherlands have launched a new fund to encourage Dutch scientists to test the reproducibility of ‘cornerstone’ scientific findings. The €3 million fund was announced on July 19th by the Netherlands Organisation for Scientific Research (NWO) and will focus on replicating work that “have a large impact on science, government policy or the public debate.”

The Replication Studies pilot program aims to increase transparency, quality, and completeness of reporting of results. Brian Nosek, who led studies to evaluate the reproducibility of over 100 reports from three different psychology journals, hailed the new program and stated “this is an increase of infinity percent of federal funding dedicated to replication studies.” This project is the first program in the world to focus on the replication of previous scientific findings. Dutch scientist Daniel Lakens further stated that “[t]his clearly signals that NWO feels there is imbalance in how much scientists perform replication research, and how much scientists perform novel research.” The NWO has stated that it intends to include replication in all of its research programs.

This pilot program will focus both on the reproduction of findings using datasets from the original study and replication of findings with new datasets gathered using the same research protocol in the original study. The program expects to fund 8-10 projects each year, and importantly, scientists will not be allowed to replicate their own work. The call for proposals will open in September with an expected deadline in mid-December. (Monya Baker, Nature News)

Health Care Insurance

US Sues to block Anthem-Cigna and Aetna-Human mergers

United States Attorney General Loretta Lynch has announced lawsuits to block two mergers that involve four of the largest health insurers. Co-plaintiffs in the suits include eight states, including Delaware, Florida, Georgia, Illinoi, Iowa, Ohio, Pennsylvania, Virginia, California, Colorado, Connecticut, Main, Maryland, and New Hampshire, as well as the District of Columbia. The lawsuits are an attempt by the Justice Department to block Humana’s $37 billion merger with Aetna and Anthem’s $54 billion acquisition of Cigna, the largest merger in the history of health insurers. The Justice Department says that the deals violate antitrust laws and could mean fewer choices and higher premiums for Americans. Antitrust officials also expressed concern that doctors and hospitals could lose bargaining power in these mergers.

Both proposed mergers were announced last year, and if these transactions close, the number of national providers would be reduced from five to three large companies. Furthermore, the government says that Anthem and Cigna control at least 50 percent of the national employer-based insurance market. Lynch further added that “competition would be substantially reduced for hundreds of thousands of families and individuals who buy insurance on the public exchanges established under the Affordable Care Act.” The Affordable Care Act (ACA) aimed to encourage more competition between insurers to improve health insurance options and keep plans affordable. The Obama administration has closely watched the health care industry since the passing of that legislation and has previously blocked the mergers of large hospital systems and stopped the merger of pharmaceutical giants, such as the proposed merger of Pfizer and Allergan.

Health insurers argue that these mergers are necessary to make the health care system more efficient, and would allow doctors and hospitals to better coordinate medical care. In reaction to the announcement by the Justice Department, Aetna and Humana stated that they intend to “vigorously defend” the merger and that this move “is in the best interest of consumers, particularly seniors seeking affordable, high-quality Medicare Advantage plans.” Cigna has said it is evaluating its options. (Leslie Picker and Reed Abelson, New York Times)

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July 26, 2016 at 11:00 am