instruction:
Given a paragraph, generate a claim that is supported by the given paragraph. 1) The claim must contain information from within the paragraph. 2) A sentence within the paragraph can be used as a claim. 3) The claim should not have contradictions within the paragraph. 4) The claim should be at most one sentence long.
question:
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.
answer:
FDA approves new, targeted treatment for bladder cancer


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The World Health Organisation has urged countries to widen testing to contain the virus. Malaysia’s tally of infections has jumped six-fold in just ten days to more than 1,500, exceeded only by China, South Korea and Japan in Asia. By the end of the week, Malaysia will double daily testing capacity to 7,000, before stepping that up to 16,500 by the first week of April, the official, Noor Hisham Abdullah, said. “We are preparing for the worst scenario, but hope for the best outcomes,” Noor Hisham, the director general of Malaysia’s health ministry, added in a text message late on Monday. “Once we have the capacity ready, we will scale up active case detection, testing, isolation and treatment.”  Ministry data shows Malaysia had done 17,923 tests by Monday, when the biggest daily increase of 212 new infections took the country’s total to 1,518. That works out to about 560 tests per million people, fewer than neighboring Singapore’s 4,500 tests per million, according to the city-state’s most recent data, but well above Indonesia’s  single-digit figures. Malaysia has recorded at least 14 virus deaths. It has linked nearly two-thirds of its infections to a religious gathering last month near the capital, Kuala Lumpur, that the government says drew more than 16,000 people. The event is also linked to more than 100 cases across Southeast Asia. On Monday, Prime Minister Muhyiddin Yassin said Malaysia may extend beyond the end of the month travel and movement curbs imposed to contain the spread of the virus. [nL4N2BG1XK]
answer:
Malaysia steps up coronavirus tests as it braces for 'worst scenario'.


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Oly Ilunga has overseen Democratic Republic of Congo’s near year-long response to what is the second deadliest Ebola outbreak in history. It has killed more than 1,700 and been declared an international health emergency by the World Health Organization (WHO). President Felix Tshisekedi on Saturday appointed a team led by Jean-Jacques Muyembe, the head of Congo’s biomedical research institute, to coordinate the government’s response in Ilunga’s place. In his resignation letter, the minister criticised pressure by unnamed “actors” to deploy the second vaccine, manufactured by Johnson & Johnson and backed by the WHO. It has yet to be used on the ground due to Ilunga’s objections. It is designed to complement a Merck treatment that has been given to 170,000 people and proved effective. Ilunga has said the J&J vaccine has not been proved effective and that deploying a second one would confuse people in eastern Congo, where health workers are struggling to overcome widespread misinformation about the haemorrhagic fever as well as sporadic hostility. Ilunga said it would be “fanciful to think that the new vaccine proposed by actors who have shown an obvious lack of ethics by voluntarily hiding important information from medical authorities, could have a significant impact on the control of the current outbreak”. J&J says the vaccine has been tested on more than 6,000 volunteers and raised no particular safety concerns. Its chief scientific officer, Paul Stoffels, said in a telephone interview that the company had been “very transparent, very open and in full communication” with Congolese authorities. He said J&J had discussed with Muyembe how people could be vaccinated around eastern Congo’s biggest city, Goma, where a first Ebola case was confirmed last week, to create a protective “curtain”. “Whether they use it or not, it’s fine for us,” said Stoffels, referring to Congolese officials. “They have to judge based on their personal knowledge of how and where to use it.”   The WHO and other international donors including medical charity Medecins Sans Frontieres have publicly supported using the second vaccine, of which 1.5 million doses are available. A WHO spokesman said the organisation was grateful for Ilunga’s leadership and dedication and looked forward to “working closely with the new coordination team as we have with the previous one”. Last week, the organisation labelled the outbreak an international emergency, a rare designation aimed at galvanising global support as it threatens to gain a foothold in neighbouring Rwanda and Uganda. Only the 2013-16 epidemic in West Africa that killed more than 11,000 people has been deadlier.
answer:

Congo minister's resignation over Ebola snub could unblock new vaccine.