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Generate an explanation for the given claim using the provided supporting material from the paragraph. Please consider the following points while generating an output. 1) The claim will always have supporting proof in the paragraph, and the paragraph will have a clear point of view supporting the claim. 2) There can be instances where direct correlation to the claim is not available. Make use of the sentences in the paragraph to provide a corresponding output supporting the claim. 3) The explanation should be at least one and at most twelve sentences long.
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Paragraph: The release does not mention cost. The FDA evaluates drugs without consideration of cost, so it’s understandable that they wouldn’t comment on it — and that’s why we’re rating this Not Applicable. But let’s be real here: The value of a new drug is a function not just of how well it works, but its cost-effectiveness. So we look forward to the day when any news release about a new drug — even one from the FDA — will include some mention of cost in its message. This release gives the preliminary results from a single study of 310 patients. Because the drug is experimental, long-term results haven’t been studied. Of the 310 patients enrolled in the lone trial upon which the approval is based, 14.8 percent showed some shrinkage of tumors during the assessment period lasting from 2.1 to about 13.8 months. For a subset of patients who were classified as having a positive response to PD-L1 expression, the response was 26 percent. As noted above, tumor shrinkage doesn’t always lead to improvements in survival or quality of life. It is a surrogate endpoint — a substitute — for the main outcome which is survival. Although this drug looks promising, to be fully transparent about its benefits as currently known, the release should have explained this. As noted in the “Summary,” another larger study is underway to assess the drug’s impact on extending life and improving quality of life. The release includes a description of side effects of this treatment. The most common ones included fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. The release also mentions that patients taking the drug have an increased risk of infection and serious side effects that are “immune-mediated.” We would have liked a bit more context on what this term means for patients. The release outlines that this is the very first clinical trial of this compound for safety and efficacy, and under which regulatory paths the drug was assessed, including “breakthrough therapy designation, priority review status and accelerated approval.” We’re giving this release the benefit of the doubt and rating it Satisfactory for its bare bones description of the trial (and since we already addressed the lack of long-term survival data in the “Benefits” section.) As it stands, the results from the small trial were preliminary and short-term and did not reflect long-term survival. We would have liked to see a reference or link to the completed trial where one could look at the results to assess independently or learn more about the outcomes. We think the release should have provided more data on the patient demographics, the treatment regimen (dosing amount and schedule) as well as the range in tumor reduction. There is no disease mongering. This release describes the approval of a new drug by a regulatory agency, but we’d still like to know who sponsored the study that’s the basis for the approval. It’s not enough to state who markets the drug. The release does not give us very much information about alternatives. These patients had already received other therapy and their cancer had recurred, so it is implied that they had no other alternatives. But this isn’t stated very clearly. We can assume (and it seems evident) that the platinum-based therapy that the patients didn’t respond to initially is the usual treatment. The FDA’s approval of a drug clears the way for the drug sponsor to scale up production and begin marketing and selling the product. (The FDA doesn’t state this explicitly but it can be inferred.) A NYT article said the drug would be available in about two months. The release clearly states this product is first of its kind for this type of cancer. We found no unjustifiable language. Claim: FDA approves new, targeted treatment for bladder cancer
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The Food and Drug Administration approved a new immunotherapy drug that acts as a “checkpoint” inhibitor in patients whose bladder cancer (urothelial carcinoma) has not responded to other chemotherapy. The drug, atezolizumab (marketed as Tecentriq), showed effectiveness in about 14 percent of 310 patients in a very preliminary study. The release notes that the trial measured tumor shrinkage as the main outcome. It didn’t note, as a NYT article did, and important for this type of trial, that it is unknown whether the treatment makes a difference in survival. A larger study is being done to examine this. Whether it makes a difference in quality of life is also important and will presumably be examined in the larger trial. The National Cancer Institute (NCI) estimates 76,960 new cases of bladder cancer and 16,390 deaths from this disease in 2016. This approval of a new drug for treating bladder cancer is part of a wider area of research into immunotherapy, in which drugs target mechanisms of the human immune response. Patients with the PD-L1 protein highly expressed in their tumors appear to be responding best to the drug. This drug is an example of targeted chemotherapy which is becoming more important as treatments can be fine-tuned to the cancers of individual patients. In patients with intractable cancers, immunotherapy appears to offer some new hope while also bringing sobering questions about affordability and disparity of access by income. The drugs are typically very expensive — with some estimates putting the treatment cost for a single patient as high as $1 million. When the FDA gives a compound a “breakthrough” designation, some physicians and patients can misunderstand what that means. That’s a topic recently explored in this post.


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Paragraph: "Senate Republicans’ surprise move to repeal the requirement to have health insurance into their tax reform bill revealed numbers that few people had noted before. (The mandate says that everyone must have coverage or face a fine.) ""80 percent of the tax falls on those who make $50,000 a year or less,"" Sen. John Thune, R-S.D., told Fox News Nov. 15. ""We’re taking a failed policy that punishes people with taxes -- low-income people. (We’re) taking that tax away, giving them tax relief there, and then ploughing that back into tax relief for middle-income families."" This was no throw-away line. Thune is the third-ranking Republican in the party’s Senate leadership, and his colleagues delivered similar versions of the talking point throughout the day. In 2016, the fine for not having insurance stood at $695 for adults. The formula has a few wrinkles that brought the maximum penalty to $2,085 for a family, or 2.5 percent of income, whichever was larger. Going forward, it rises with inflation (unless of course, Congress repeals it). Not everyone without insurance has to pay the fine. The list of exemptions is long. It includes a family with income under $20,800; people who have suffered domestic violence in the household; anyone who has suffered the death of a close family member; someone who has received a utility shut-off notice, and more. Thune’s office said he got his information from 2015 data from the Internal Revenue Service. In one key sense, Thune is correct. Out of all the tax returns sent to the IRS that included a payment of the fine, 79 percent came from households making $50,000 a year or less. (Technically, the income is adjusted gross income, which understates actual income. But on average, the adjustment makes little difference for this check.) However, Thune didn’t specify that he was talking about the number of people. His description of the tax could just as equally refer to the dollars paid. The government collected a little over $3 billion from about 6.6 million households. Of that, about $1.8 billion, 60 percent, came from households with incomes under $50,000. So in dollar terms, about 60 percent of the tax fell on people in that income range, not the 80 percent that Thune said. Thune’s communications staff told us he was talking about the number of people and the number of returns. We reached several health care and tax researchers, and none of them challenged the core numbers. Gordon Mermin with the Urban-Brookings Tax Policy Center ran the numbers and found that as a percentage of income, the tax fell heaviest on the $25,000 to $50,000 group. On average, that group paid 3.1 percent of income. Mermin told us households in this range are more likely to lack insurance, and due to their incomes, are less likely to be able to claim an exemption from the fine. ""People shouldn’t be surprised the $25,000 to $50,000 group is affected the most,"" Mermin said. But researchers found it odd that people making less than $25,000 had paid as much as they did. The $10,000 to $25,000 group accounted for 22 percent of the payments, and about 36 percent of the households. ""Folks are just making a mistake,"" said Jonathan Gruber, one of the architects of Obamacare and an economist at the Massachusetts Institute of Technology. ""Given the exemptions, there is no way such low-income folks should be paying."" The IRS knows this has happened. It’s been sending out letters since 2015, telling filers ""it appears that you may have reported owing too much Health Care Shared Responsibility Payment,"" the penalty’s formal name. ""The IRS has reached out to some taxpayers to let them know they’ve overpaid the penalty, but they don’t have the capacity to do that in all cases,"" said Tara Straw at the Center for Budget and Policy Priorities, a liberal-leaning think tank. Straw said the IRS targets people who automatically qualify for an exemption because of their income, a factor that is stronger in states that did not expand Medicaid to people making 138 percent of federal poverty. Where the IRS effort falls short, she said, relates to personal circumstances such as a death in the family or a utility service cut-off notice. Larry Levitt at the Kaiser Family Foundation, a neutral source of health care data, also agreed that ""there certainly appear to be some low-income people paying the penalty who could be claiming an exemption."" A just-released study from Kaiser suggests the number could be large. The report found that about 5 million uninsured people could get coverage for less than the cost of the penalty. Thanks to the subsidies in Obamacare, the lowest-level plans would be free to many of those people, or if not free, available at a very low cost. If  everyone took advantage of those subsidies, the 6.6 million households paying the penalty because they lack coverage would fall significantly. We don’t know how the numbers would shake out because about 4 million people neither paid the fine nor told the IRS that they had coverage. Republicans offer the repeal of the penalty as a boon to working Americans, and for some it would be. But the Congressional Budget Office, the nonpartisan analytic arm of Congress, has found that removing the penalty makes it less likely that people will seek out insurance, even if it would be free or very affordable. Thune said that 80 percent of the individual mandate penalty falls on those who make $50,000 a year or less. In terms of the number of returns in which people paid the fine, that figure is correct. In terms of the dollars collected, it overshoots the mark. People in that income range account for about 60 percent of the payments. Still, an independent analysis showed that households in the $25,000 to 50,000 income range paid the highest percentage of income on the penalty. There’s strong evidence that many lower income people are paying the fine by mistake, and millions could both avoid it and gain health coverage for less than the cost of the fine. But as far as who is paying the fine." Claim: 80 percent of the (individual mandate) tax falls on those who make $50,000 a year or less.
answer:
Thune said that 80 percent of the individual mandate penalty falls on those who make $50,000 a year or less. In terms of the number of returns in which people paid the fine, that figure is correct. In terms of the dollars collected, it overshoots the mark. People in that income range account for about 60 percent of the payments. Still, an independent analysis showed that households in the $25,000 to 50,000 income range paid the highest percentage of income on the penalty. There’s strong evidence that many lower income people are paying the fine by mistake, and millions could both avoid it and gain health coverage for less than the cost of the fine. But as far as who is paying the fine. 


question:
Paragraph: Lithuania’s new liquor law has increased the legal drinking age from 18 to 20, banned alcohol advertising, and drastically curtailed opening hours for liquor stores. The law, in effect since Jan. 1, has stirred major controversy in this Baltic nation of 2.9 million people. According to the World Health Organization, Lithuanians’ per-capita alcohol consumption jumped more than 22 percent in a decade — from 14.9 liters (15.7 quarts) of pure alcohol annually in 2006 to 18.2 liters (19.2 quarts) in 2016. Authorities felt drastic measures were needed. “We had to do something about it,” said Health Minister Aurelijus Veryga, the main proponent of the new legislation. (Alcoholism) “makes Lithuania unattractive to foreign investments and tourism.” “Especially shocking are surveys showing that a third of our 15- and 16-year-olds consume alcohol regularly,” Veryga noted. With 36 per 100,000 people, Lithuania has the highest suicide rate in Europe, and suicide rates among alcoholics are consistently high, according to a study conducted by health specialists at Vilnius University. “These were hard decisions,” Veryga said, noting that opponents of the new law were trying “to make fools” of its supporters, including him. Veryga became minister in late 2016 when his party — Union of Farmers and Greens Union — claimed most seats at the national elections. The party has pushed ahead with several conservative law changes in family policy, despite public protests and disagreements with coalition partners. On a mural covering a wall of a popular Vilnius restaurant, Veryga is depicted as a Taliban fighter holding an AK-47 machine gun under the heading “the party is over,” reflecting concerns that Lithuania is entering a dark era of radical bans and restrictions. Some columnists suggested Lithuania should start censoring classic literature describing the consumption of spirits, while members of the opposition have already filed amendments seeking to repeal the harshest aspects of the law. Even the country’s president, Dalia Grybauskaite, has called for amendments. “It reminds me of the Middle Ages and it causes huge international harm to Lithuania’s image and reputation abroad,” Grybauskaite said, speaking about pages having to be torn out of foreign magazines. Publishers have rushed to remove — or cover with red stickers — liquor ads from foreign publications distributed in the country to avoid fines of 30,000 euros ($37,480) per ad. Analysts point out that the new laws are being pushed through without any dialogue, disregarding unwanted side-effects, international practices or even common sense. “Their political program is a collection of random ideas wrapped in Messianism and shrouded in hypocrisy,” said Zilvinas Silenas, president of the Lithuania Free Market Institute, a Vilnius-based think tank. “But they are very consistently prohibitionist about regulating personal choice and lifestyle.” “The party has no identity except for a crusade against what people put in their mouths,” Silenas added. Restaurants have also been affected. Wine bottles are no longer allowed to be displayed after 8 p.m. as its labels are considered advertising and patrons have a choice of buying wine by the glass or having it served in a decanter. “This is just ridiculous,” said Arunas Starkus, study director at the Sommelier School of Lithuania, calling the new rules “simply irrational and naive.” “It takes decades to change people’s customs and it has to be done by changing the culture, not by implementing restrictions and penalties,” Starkus said. Underage drinkers are still welcome at many downtown bars, with owners highly skeptical about the new regulations. “Of course, we let in everybody, even those who are under 20,” said Raminta Ruibyte, manager of a popular Vilnius bar. “We can offer them non-alcoholic beverages.” Minister Veryga, for his part, was unmoved. “Nobody will solve these problems for us,” Veryga said. “We must ... help the new generation grow up not thinking that alcohol is the main factor that unites and keeps our society together.” Claim: Stricter liquor rules give Lithuanians a severe hangover.
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One of the heaviest drinking nations in the world is facing a severe hangover.