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.

Eighteen people who became ill attended the private function Nov. 24 at the Puritan Backroom conference center in Manchester, the state Department of Health and Human Services said. The person who later died was an adult from Hillsborough County. No other details were issued about the person, in accordance with federal and state privacy laws. The state medical examiner’s office completed its final report Tuesday after conducting an autopsy last month. The restaurant is co-owned by U.S. Rep. Chris Pappas. It has been in his family for more than a century and is a frequent stop for presidential candidates of both parties. The manager of the Puritan Backroom said recently that the restaurant’s top priorities are promoting health and excellent food safety and that he was confident it was doing everything possible to maintain those practices. After the outbreak, the Manchester Health Department conducted an inspection of the restaurant. Officials determined there was no ongoing norovirus risk to the public. Symptoms include diarrhea, vomiting, nausea and stomach pain.
Officials: Norovirus contributed to restaurant patron death.

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.
FDA approves new, targeted treatment for bladder cancer

At a hearing in Miami federal court, U.S. District Judge Patricia Seitz said she expects more concrete action and fewer promises from Carnival. “We’re not there. And we should be,” Seitz said. The cruise company is about halfway through a five-year probation sentence for a 2016 criminal pollution conviction. Chairman Micky Arison, who also owns the Miami Heat, and CEO Arnold Donald both insisted the company is doing a lot, but that it takes time to implement real changes at a company with 120,000 employees, more than 100 cruise ships and nine different brands. “We strive to be perfect,” Arison told the judge. “We won’t ever be perfect, but we are going to work toward that.” Earlier this year, Carnival admitted violating probation from the 2016 criminal case as its ships continued to cause environmental harm around the world since then. It was hit with a $20 million penalty, on top of a $40 million fine imposed in the original case. The environmental problems included allowing plastic to be discharged along with food into water; dumping “gray water” in prohibited places such as Alaska’s Glacier Bay National Park; and permitting a corporate culture to persist that does not value compliance with environmental laws. Richard Udell, a Justice Department lawyer specializing in environmental enforcement, cited the recent inability of Carnival to detail what happens to the estimated 50 million plastic bottles used on its ships each year. Carnival, he said, simply told the government they don’t keep track of that because they are all supposedly recycled at some of its 700 destinations. Prosecutors want to know if that is really the case, or if often the bottles simply get dumped in the ocean or in landfills by other entities where Carnival ships dock. “If we don’t look, we won’t know, and if we don’t know, we don’t care,” Udell said. “We hope that we can get past this.” Carnival outlined many steps it is taking to phase out use of plastics on its ships, including the bottles, and that it would look deeper into the recycling issue. And Donald, the CEO, said the company’s leadership is making every effort to value environmental compliance just as much as ship safety and guest hospitality. “Compliance, environmental protection, safety _ it’s the first thing,” Donald said. “Without it, we don’t have a business.” Another status hearing is set for December. _____ Follow Curt Anderson on Twitter: http://twitter.com/Miamicurt

Judge: Carnival must fix ocean pollution issues faster.