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.

Ex Input:
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

Ex Output:
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.


Ex Input:
Paragraph: Major European stock markets dived more than 7%, Japanese indexes fell over 5% and U.S. markets sank over 7% after Saudi Arabia launched an oil price war with Russia that sent investors already spooked by the coronavirus epidemic running for the exits. In Italy, scene of Europe’s worst outbreak with infections and deaths still soaring, the government took its most drastic steps yet to contain the outbreak, affecting some 60 million people. It ordered everyone across the country not to move around other than for work and emergencies, banned all public gatherings and suspended sporting events, including soccer matches. Deaths in Milan’s Lombardy region - which had already been on lockdown with cinemas, theaters and museums closed and restaurant hours restricted - jumped 25% in a day to 333, while the national death toll soared by 97 to 463, the highest in the world after China. Over 9,000 people have become infected in Italy in little over two weeks, out of a global total of more than 113,000 in over 100 countries. Nearly 4,000 people have died across the world, the vast majority in mainland China. “Now that the virus has a foothold in so many countries, the threat of a pandemic has become very real,” World Health Organization Director-General Tedros Adhanom Ghebreyesus told a news conference. But he welcomed Italy’s tough measures, noting that just four countries - China, South Korea, Italy and Iran - accounted for 93% of cases worldwide. Israel ordered anyone entering the country to self-quarantine for 14 days on Monday. “It would be the first pandemic that could be controlled,” Tedros added. “The bottom line is we are not at the mercy of the virus.”  In the United States, which has reported over 600 cases and 26 deaths, the administration scrambled on Monday to assure Americans it was responding to the outbreak as stock markets plunged and top health officials urged some people to avoid cruise ships, air travel and big public gatherings. U.S. President Donald Trump, who continued to play down the threat posed by the flu-like virus, said he would announce economic measures on Tuesday and would discuss a payroll tax cut with Congress to bolster the economy. Trump recently spent time with two members of Congress, including one who rode on Air Force One, who are self-quarantining over concerns about exposure to the virus. Vice President Michael Pence said he did not know if Trump had been tested for coronavirus. Around the world, flights have been canceled, communities and cruise liners isolated, and concerts and trade fairs postponed. While some countries, such as China and Italy, have turned to drastic measures to try to delay the spread of the virus, others remain in a “containment” phase, where individual cases can still be tracked. Britain, with five deaths from almost 300 confirmed cases, said it would remain in that phase for now, allowing major gatherings and sporting events to continue, while making extensive preparations to move to the “delay phase.”  In neighboring Ireland, acting Prime Minister Leo Varadkar said a 3 billion euro ($3.4 billion) coronavirus package had been agreed. Funds set aside for a potential sudden rupture in trade ties with Britain, which has left the European Union, were to be diverted to coronavirus mitigation. Perhaps just as dramatically, Varadkar announced  cancellation of all parades planned for the national St. Patrick’s Day festival on March 17, including one in Dublin that draws more than 500,000 people from all over the world. In Spain, schools were closed across the Madrid region and the Basque capital Vitoria for two weeks as cases topped 1,200 nationwide. Prime Minister Pedro Sanchez said an emergency economic plan had been prepared. In the Gulf region, where most cases stem from travel from Iran, the emphasis has been on border control. Saudi Arabia said it would fine people who did not disclose health information and travel details at entry up to $133,000. Iran, with 7,161 cases and 237 deaths, said it was temporarily releasing about 70,000 prisoners because of the coronavirus. China and South Korea both reported a slowdown in new infections. Mainland China, outside the outbreak center of Hubei province, recorded no new locally transmitted coronavirus cases for the second day. South Korea reported 165 new cases, bringing the national tally to 7,478, while the death toll rose by one to 51. With the rate of increase in new infections at its lowest  in 11 days, President Moon Jae-in said South Korea could enter the “phase of stability” soon. In Italy, that phase still seems far off. Authorities said seven prisoners died as riots spread through more than 25 jails across the country over measures imposed to contain the coronavirus. Police and fire trucks massed outside the main prison in the northern town of Modena, the site of some of the worst violence. Barkeepers in Rome and Milan said police had visited them to warn that they risked closure if they let customers huddle together. “We went into the cafe together but were told to stand far apart. It was really odd because we are friends,” said Ilaria Frezza, a 21-year-old student. But the bar she was in was, in fact, almost deserted. “I wish I was having problems keeping people apart, but that’s the least of my worries,” said Franco Giovinazzo, who runs the Spazio Caffe in Rome. “The real problem is there’s no-one here.”  (Graphic: Coronavirus spreads in China and beyond, here)  (Graphic: Tracking the novel coronavirus, here)  (Online package of coronavirus news, here) Claim: Stocks savaged, Italy on lockdown, Trump seeks to reassure as coronavirus spreads.

Ex Output:
All of Italy under lockdown, reeling financial markets and rioting prisoners made clear on Monday how the global coronavirus epidemic was extending its reach into all aspects of social and economic life.


Ex Input:
Paragraph: International aid agencies as well as North Korea state media have been warning that erratic weather with drought and floods, and a lack of access to resources could lead to a food crisis in a country under strict international sanctions over leader Kim Jong Un’s pursuit of nuclear weapons and ballistic missiles. “We are already seeing the impacts of this drought on vulnerable people,” Mohamed Babiker, head of the IFRC’s office in North Korea, said in a statement. “Rates of malnutrition and water borne diseases like diarrhea and colitis are on the rise.”  After an assessment in May concluded that this year’s harvest would be less than half what it should be, the IFRC spent 250,000 Swiss francs ($253,787) on deploying mobile water pumps, which were able to double crop yields in the targeted areas, the organization said. “Water pumps and irrigation supplies can make a significant difference,” Babiker said, calling for an additional 472,000 Swiss francs ($479,284) for more agricultural and sanitation supplies. North Korea increased imports of fertilizer and food products last year, according to trade data compiled by the United Nations. But the Center for Advanced Defense Studies (C4ADS), a Washington-based think tank, documented in a report this week how North Korea also continues to import millions of dollars worth of luxury goods, including at least two armored limousines valued at $500,000 each. South Korea’s intelligence agency told lawmakers on Tuesday that drought had hit the North Korean economy which already faces difficulties such as widening trade deficits, foreign currency shortages and a deepening cash crunch due to sanctions. Rainfall in North Korea has fallen by more than 30% this year from a year before, and there are signs of a deteriorating food situation, according to Lee Eun-jae, one of the lawmakers briefed by the spy agency. “North Korea is expected to exhaust its crop reserves earlier than usual this year,” Lee told reporters. South Korea has said it would donate $4.5 million to the U.N. World Food Programme (WFP), and announced it was also providing 50,000 tonnes of rice for delivery to its northern neighbor. South Korea also recently donated $3.5 million to the U.N. Children’s Fund (UNICEF) for humanitarian projects in North Korea. Last week, North Korea state news agency KCNA said a campaign to mitigate the effects of drought was under way by digging canals and wells, installing pumps, and using people and vehicles to transport water. The official television broadcaster on Monday warned of further damage in the upcoming rainy season. It said the country suffered from floods in June, showing submerged buildings and villages where houses were destroyed by landslides. Sporadic famines are common in North Korea, according to experts based in South Korea, but in the 1990s, a nationwide famine killed as many as one million people. Claim: Malnutrition, disease rising in North Korea: aid organization.

Ex Output:

Rates of malnutrition and disease are increasing in North Korea as it faces a harvest that is half of what was expected, the International Federation of Red Cross and Red Crescent Societies (IFRC) said on Thursday.