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Posts Tagged ‘UK

Science Policy Around the Web – April 12, 2019

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By: Saurav Seshadri, PhD

Photo by Elijah Hiett on Unsplash

With Vertex, NHS back at the pricing table, CF advocates ratchet up the pressure

petition demanding coverage of the cystic fibrosis (CF) drug Orkambi in the UK has now garnered over 100,000 signatures, and must therefore be considered by Parliament for debate.  The milestone is the latest development in the struggle between Orkambi maker Vertex Pharmaceuticals and the British government, which began soon after Orkambi was approved in 2015.  The main point of contention is the price of the drug.  The UK’s National Institute for Health and Care Excellence (NICE) has refused to recommend Orkambi at Vertex’s asking price of £104,000 ($136,000) per patient per year, but Vertex has rejected the UK’s offer of £500 million for 5 years’ access, leaving both parties at an impasse.

The UK is not the first country to clash with Vertex over pricing. Several health agencies have refused to pay for Orkambi on the grounds that it is only marginally effective; some now face lawsuits, as programs like Medicaid are required to provide available drugs for qualifying patients.  While Orkambi is not as effective as Vertex’s first drug Kalydeco, it can be prescribed to more patients (up to 50% of those with CF).  Life expectancy for patients with CF is less than 40 years, and many patients are children, so even small improvements can be life-changing.  However, as with the multiple sclerosis drug Ocrevus, NICE seems unlikely to relent; on the contrary, UK Health Minister Matt Hancock recently accused Vertex of ‘hold[ing] the NHS to ransom’ and ‘profiteering’.  

For its part, Vertex is unlikely to compromise on the price of its best-selling drug, which brought in $1.26 billion in 2018.  CEO Jeffrey Leiden insists that this revenue is critical to the company’s continued investment in CF research.  Ironically, this stance may be pushing the UK closer to a measure that would jeopardize all future medical R&D efforts: invoking ‘Crown’ use, which allows the government to sell a patent without the consent of its owner. While the idea has gained support among some British lawmakers, and has been used in the past (to make Pfizer-owned antibiotic tetracycline available in the 1960s), it would face legal challenges that could render it ineffective.  But with public pressure mounting, especially after Vertex recently admitted to destroying almost 8,000 packs of Orkambi amid the standoff, inaction may not be an option for much longer.

(Eric Sagonowsky, FiercePharma)


Why some low-income neighborhoods are better than others

A recent study, published in PNAS, builds upon a body of evidence that while race can influence upward mobility (with white children having a 4-fold higher chance of moving from the lowest to highest income brackets than their black peers), environmental factors also play a major role.  Previous work demonstrated that the neighborhood in which a child grows up has a large effect on their future success, with better outcomes for children raised in low-poverty neighborhoods, regardless of race.  However, black children are significantly less likely to live in such neighborhoods.  To combat racial inequality, it is critical to understand which aspects of poverty impact long-term socioeconomic progress. 

The new study is based on the Opportunity Atlas, and pulls together data from tax returns, Census surveys, police reports, prison admission records, and blood tests conducted by the health department. The data tracks a cohort of children born in 1978-1983 (age 31-37 in 2014), living in 754 Census tracts in Chicago.  The authors report that even after controlling for other variables, a large proportion of the racial disparity observed in adults can be explained by three factors: violence, incarceration, and lead exposure during adolescence.  Since these factors were highly correlated with each other, the authors combined them into a single ‘neighborhood harshness/toxicity’ factor; this variable proved to be a much stronger predictor of income, incarceration, and teen pregnancy than more traditional factors, such as poverty or college education rates.   

That these elements impair social mobility is perhaps not surprising, as exposure to both violence in the community and high levels of lead have both been linked to cognitive impairment. But the magnitude of the effect is striking: for example, according to their model, toxicity exposure could account for 60% of the difference in incarceration rates between black and white men in their sample, and a 10% increase in teen births among black women.  While the authors acknowledge they cannot establish causality, they conclude that ‘Chicago’s residential segregation is disproportionately exposing its black children to neighborhoods that are hazardous to their development’.  Recently elected mayor Lori Lightfoot ran on a platform that includes stopping violence, expanding affordable housing, and ‘investing in our neighborhoods’.  Insight into the mechanisms that perpetuate inequality can only enhance these policies’ power to improve the trajectories of vulnerable kids.      

(Sujata Gupta, Science News


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Written by sciencepolicyforall

April 12, 2019 at 5:21 pm

Science Policy Around the Web – July 19, 2016

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By: Emily Petrus, Ph.D.

Photo source: digitaltrends.com

Data Mining

Big Data Fighting Terror

How do we stop terrorist attacks before they happen? The US Department of Defense (DOD) has projects dedicated to maintaining our military prowess; however, a new branch of science may be our best bet in fighting this increasingly sinister opponent. Managing huge sets of data from multiple sources presents a challenge for our intelligence and military organizations as we scramble to thwart acts of terror. This involves identifying target locations, suspects and reacting quickly and/or proactively.

After the terror attacks of 9/11, the Patriot Act was passed to allow the government unprecedented access to data from Americans, including bulk phone metadata – famously leaked by Edward Snowden after working for the National Security Agency. Although this type of data is no longer accessible since the bill expired in 2015, the government now has more data than it knows how to handle from social media platforms such as Twitter and Facebook. The National Science Foundation and the DOD are seeking interdisciplinary approaches to efficiently analyze huge data sets and enhance predictive abilities to spot potential terror suspects or events.

It is estimated that ISIS members make up to 90,000 posts on social media per day, so sifting through these posts is a challenge being tackled by researchers and data miners. A 2015 paper looked at 3.1 million Arabic tweets related to ISIS from 250,000 different users over the span of a few years. Using big data analytics they were able to use present tweets to determine if users were pro or anti-ISIS. After identifying users’ present status, they used an algorithm to look at past tweets and predicted which users became ISIS supporters with 87% accuracy.

Our country must weigh the benefits of using big data to foil terror plots before they happen against the loss of privacy. Just this month the House of Representatives voted to block expansion of the Patriot Act, which would have allowed banks to share information with federal authorities of those suspected of funding terrorism. America may be the land of the free, but like France, this leaves us vulnerable to opportunistic terrorists.

GMOs

House gives thumbs-up to GMO label law; bill goes to Obama

Food labels are about to get more complicated: a law proposed by the Senate was passed by the House of Representatives on July 14th will require foods containing genetically modified organisms (GMOs) to be labeled. The labels will be designed with United States Department of Agriculture (USDA) oversight, and can include text, a logo, or a Quick Response (QR) smartphone code. The federal government was pushed to action by the recent legislation in Vermont, which required GMO labeling for foods in grocery stores. This caused many food products to be removed from sale in Vermont such as Coca-Cola, Sabra Hummus, and Heinz Ketchup because companies did not have the motivation or time to prepare labels for Vermont’s new law.

The benefits of passing a law reduces the patchwork of laws bound to spring up in other states, which decreases the burden of individual state labeling for food makers. However there is no consensus on what qualifies as a GMO, as some genetic modifications are simply via selective breeding, while others are “in the lab” like recombinant DNA techniques. Other problems with the bill are exceptions; including foods made with a GMO no longer have the genetic material after processing, which is the case with many sweeteners and cooking oils.

Although the “right to know” movement stimulated by public interest has good intentions, unfortunately the anti-GMO movement is not backed by scientific research. Recently, more than 100 Nobelaureates penned a letter to Greenpeace requesting they stop their anti-GMO campaign. They point to examples of GMO products being better for public health and the environment, as they increase food’s nutritional value and often reduce the amount of chemicals required.

Overall, the mandatory GMO labeling is a compromise bill which will increase the amount of information available about the foods we purchase. Unfortunately the variety of methods used and the complexity of genetic modification of food makes it difficult to make into a simple label for the general population’s benefit. (Jim Spencer, Star Tribune)

Brexit

Science’s status shifts in new Brexit government

The weeks following the Brexit yielded an atmosphere of chaos for British politicians, citizens and scientists as the world came to grips with what an EU exit would do for the economy and everyday lives of those in the UK. Scientists in the UK are especially anxious following the Brexit, as researchers have much at stake with a split from the EU. These include limited access to EU research dollars, less mobility for scientists seeking training opportunities and collaborations between the UK and EU, and an uncertainty for the level of support they will receive from the new UK government.

Now the UK has selected a new prime minister, Theresa May, who has been busy re-organizing government offices. A new department responsible for research funding and oversight will now be headed by Greg Clark, a previous science minister, which is positive news for the scientific community. The department of Business, Energy and Industrial Strategy (BEIS) replaces the Department for Business, Innovation and Skills which had research budget of $6.3 billion. The Department for Energy and Climate Change (DECC) also seems to be rolled into the BEIS, although some worry that without a specific department for environmental concerns, funding and priority for this research and combating climate change will fall by the wayside.

With a swift ascension to the prime minister spot and no actual campaign, scientists have very little idea if May values scientific research. In the past she has pushed to restrict visas (hampering scientist movement and training opportunities), and supported a bill to ban “designer drugs”. However scientists remain hopeful as “[s]he has been an example of good practice in gathering evidence, and also of explaining her decisions when they have not gone with the scientific advice” said Sarah Main of the Campaign for Science and Engineering in London. For the future, scientists will have to wait and see if May views science as a funding priority. (Davide Castelvecchi, Nature News)

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Written by sciencepolicyforall

July 19, 2016 at 9:00 am

Science Policy Around the Web – June 28, 2016

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By: Sterling Payne, B.Sc.

Licensed via Creative Commons

Bioengineering and Human Trials

First CRISPR clinical trial gets green light from US panel

Since its discovery, CRISPR-Cas9 has become one of the hottest and most sought-after techniques and area of research in science. Whether owing to its ease of use, wide accessibility, or myriad modifications, the research and public health worlds are captivated by CRISPR. Almost one week ago, on June 21st, the National Institutes of Health (NIH) opened the door for the first use of CRISPR in humans as a potential therapeutic in a clinical trial. The trial in question focuses on the use of T-cells to fight cancer by introducing exogenous genetic material via CRISPR-Cas9, followed by the infusion of the cells into cancer patients.

This is not the first time that a gene-editing technique has been used to edit human cells. In 2014, Carl June, an immunologist at the University of Pennsylvania and scientific adviser on the current trial, led a trial that used zinc finger nucleases to edit T-cells in hopes of preventing viral infection. However, the recent approval of this single CRISPR proposal will most likely pave the way for many more, and in a short amount of time. The advancement of CRISPR-Cas9 in the past few years and its potential use in humans is staggering. However, an influx of clinical trials involving this technique will pose more policy discussions and questions to assure scientists and the public that the technique is being used humanely and ethically. It will be interesting to see how the definitions of what is humane and ethical in the eyes of policy-holders potentially changes in the coming years thanks to CRISPR. (Sara Reardon, Nature News)

Brexit and Research

Researchers deplore U.K. decision to leave the European Union 

On June 23rd, 2016, the electorate of Britain voted in a referendum to leave the European Union, creatively named the “Brexit”. Fast forward several days, and the consequences of the vote on multiple levels – such as global markets, immigration, employment, timelines and next steps – are still being determined. At it’s core, the U.K.’s decision to leave was not largely based on research science. However, multiple British science authorities are flabbergasted by the decision, a majority of whom believe was a mistake.

With Britain’s decision to leave the EU, it will be interesting to see how policymakers deal with the inevitable battles in terms of funding, personnel, and travel. One particular talking point is the fate of the U.K.’s standing in the Horizon 2020 program, a massively financed research initiative with 9 billion British pounds of funding over seven years (2014-2020). The initiative provides a means of support for collaboration across different European countries, and if the U.K. would like to continue as a player in the initiative, they will have to make a decision now and start preparing the necessary documents necessary to become an “associate”, for example. Policymakers have a long, winding road ahead of them in order to ensure the survival of the myriad collaborations and research projects headed by Britain. (Daniel Clery, Science News)

Patent Law

The Supreme Court decision that’s shaking up biotech 

The Supreme Court recently rejected the request to hear an appeal from Sequenom (San Diego, CA), a biotech. company specializing in prenatal testing. Sequenom’s test, MaterniT21, relies on the presence of fetal DNA in the plasma of the mother, allowing for a non-invasive method of analyzing the fetus for certain conditions such as Down’s syndrome (trisomy 21). The patent for the test remained intact until 2013, where in a case against Ariosa Diagnostics, a lower court ruled the patent as invalid. The Supreme Court’s failure to hear Sequenom’s appeal means that the previous ruling stands, and that poses a problem with implications far beyond a single biotech company.

Sequenom turned to the Supreme Court for thorough consideration and a final decision on whether or not their patent remains valid, although it does rely on the naturally occurring process of fetal DNA showing up in plasma. The highest justice’s silence in this situation creates an ambiguity around all patents in the biosciences. At what point does novelty evanesce into nature? Should patents, the protectors of intellectual property, really be granted in a case where natural processes are required to retain their validity? These are the types of questions that are being asked as a result of the Court’s silence, and that could plague future investments in biotechnology, a field that is highly represented by startups. (Douglas C. Pizac, AP/STATnews)

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Written by sciencepolicyforall

June 28, 2016 at 2:30 pm

Science Policy Around the Web – May 12, 2015

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By: Daniël P. Melters, Ph.D.

Image credit: money faucet from Gts/Shutterstock

Science Funding

Uncertainly about science funding in the UK after Tories win elections

An outright victory for the Tories (conservatives) in the recent general election in the United Kingdom was unexpected based on poll-results. This means an end to the previous governing coalition and five more years for David Cameron as Prime Minister. One question that remains is what will this change in power mean for science in the UK? One of the spear points of the Tories’ program are austerity measures to reduce the deficit ($46B). Notably, no promise was made to protect science funding, even after five years of a frozen science budget. In addition, a high turnover of Members of Parliament (MP) and loss of MPs who favor science in combination with the rise of the Scottish National Party is suspected to result in policy focused on regional projects. The biggest fear is the the upcoming referendum on whether the UK will stay in the European Union (EU). Leaving the EU would be a major set-back for UK science research as about 20% of its science funding comes from the EU. The new Minister for Universities and Science is Jo Johnson, the brother of London Mayor Boris Johnson. Although not much is known where he stands on the topic of science and research, Mr. Johnson is thought to be supportive of the EU and he as spoken out on the importance of allowing students to come to the UK.

At the same time, fellow EU-member Greece has decided to use the money allocated for funding Greek science for paying for public salaries and the US House Science Committee in the US has suggested to cut NASA’s earth science budget. On the other hands, some in US congress have called for a doubling of the NIH budget, making this a very volatile time for scientific research funding around the globe. (Elizabeth Gibney, Nature News)

Global Health

Liberia is Ebola free as complications for survivors become apparent

In December 2013, one-year Emile Ouamouno died in a small village in Guinea. This is believed to be patient zero for the current Ebola epidemic in West Africa. Over 14 thousand laboratory-confirmed cases (and many more suspected) have been reported to date and 11 thousand people have died. The last confirmed case of Ebola in Liberia was on March 28th, 2015. On May 9th the World Health Organization (WHO) declared Liberia Ebola-free, the first of the three principally affected countries to successfully quell the epidemic. This is a monumental achievement for a country that reported the highest number of deaths and was made possible by community-driven societal changes around especially mourning rituals. At the peak of the epidemic in August/September 2014, Liberia reported about 400 new cases each week.

At the same time as the good news from Liberia, other reports are emerging about the many survivors of Ebola. Dr. Ian Crozier, an American volunteer with the WHO who worked in a treatment ward in Sierra Leone and who survived Ebola with treatment in the United States, has returned to Emory University Hospital. He was considered cured two months ago, but fading eye sight, intense pain, and soaring pressure in his left eye appears to be the result from a persistent Ebola infection. Besides eye problems, Crozier continues to suffer from debilitating joint and muscle pain, deep fatigue, and hearing loss. Similar problems are being reported by survivors in West Africa. The impact of these newly observed complications on society remain to be seen, besides the trauma from the Ebola epidemic and feared secondary wave of other infectious diseases. (WHO; Denise Grady, The New York Times)

Global Drug Policy

Expensive new hepatitis C and cancer drugs make it on WHO Essential Medicines List

Every two years since 1977, a committee of experts of the World Health Organization (WHO) select medications that are considered minimum medicines for a basic health-care system, based on their efficacy, safety record, and cost effectiveness. Currently, over 400 drugs and vaccines have been selected, especially drugs that target the most pressing needs in developing nations. On May 8th, this year’s Essential Medicines List (EML) was released and includes five new drugs that target hepatitis C virus (HCV) and 16 new cancer medications. Most notably, new members on this list are the pricey anti-HCV drug sofosbuvir and the anti-leukemia drug Imatinib. In the United States, a full course treatment with these drugs will cost more than $84,000 per patient. Many developing nations use the EML to help determine in which drugs they have to invest. Nevertheless, Magrini, an Italian pharmocologist who oversees the EML, says that it still takes too long for many life-saving medicines to become widely available. The EML highlights the gaps. For example, sofosbuvir’s manufacturer, Gilead Sciences Inc. of Foster City, California, sells the drug to Egypt at a discount and allows generic manufacturers in India to produce and sell in 91 poorer countries. Yet advocates criticize Gilead for not offering deals to over 50 middle-income countries. Magrini says that the list is clever tool to build momentum to lower pricing for essential drugs worldwide. (

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Written by sciencepolicyforall

May 12, 2015 at 10:50 am