TASK DEFINITION: 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.
PROBLEM: Paragraph: The Paris regional administration suspended the job of removing hazardous substances from the fire-ravaged Paris cathedral last month under pressure from labor inspectors concerned about health risks for workers. The administration had said that when the lead-removal work resumed, stricter safety procedures, new equipment and allowing much fewer workers inside at a time would “prevent any release of polluting elements to the outside.” But representatives from environmental groups and the CGT union said at a news conference Monday they don’t think the government safeguards go far enough. They asked for a regularly updated chart showing the level of lead in the air. Labor and environmental groups are also pushing for the creation of a medical center to monitor of firefighters, workers and residents. Paris Deputy Mayor Anne Souyris said updated measurements of lead levels are set for release on Tuesday. The decontamination work is scheduled to resume Wednesday, starting with the square in front of Notre Dame and adjacent streets, Souyris said. Hundreds of tons of lead that was in Notre Dame’s spire and roof melted during the April 15 fire, which came close to destroying the cathedral. Lead levels remain elevated at some spots inside and in the soil of the adjacent park and forecourt, according to the Paris regional health agency. Those areas have been closed to the public since the fire. The environmental activists and union officials said they want a containment shield built over Notre Dame to keep more lead from being released into the atmosphere. “For the efficiency of the decontamination measures within the area, it is absolutely necessary that the site is confined”, Annie Thebaud-Mony, co-founder of health and environment group Henri Pezerat, said. Notre Dame rector Patrick Chauvet acknowledged that lead can escape into the environment from a big hole in the cathedral’s roof but ruled out building a containment shield before the decontamination work resumes. Paris authorities ordered new checks of schools and day care centers in the Notre Dame neighborhood and recommended blood tests for children under age 7 and pregnant women who live nearby. Children are especially vulnerable to health problems from lead poisoning and exposure. Claim: France: Groups want Notre Dame enclosed during lead cleanup.

SOLUTION: Environmental groups and one of France’s largest labor unions called Monday for a containment shield and other safety measures to ensure decontamination work at Notre Dame Cathedral does not expose workers and residents to unsafe levels of lead.

PROBLEM: Paragraph: "The story had a sidebar explaining the cost of Bod Pod testing in Puget Sound locations ranges from $25 – 50. The story indicated one might benefit from the information generated by BOD POD measurement by helping set realistic weight loss goals. It did not actually provide the reader with any information about whether evidence exists demonstrating that it is of benefit for weight loss or improvement in adiposity-related risks. The story indicated that obtaining body composition information could be anxiety or guilt provoking. Although the story stated that ‘Data suggest the BOD POD is accurate’, it didn’t actually indicate what sort of evidence exists documenting this. While there may be evidence that the BOD POD is ""accurate"" the story did not state whether the evidence is solid or controversial. Most importantly, the story did not address the question as to whether there is any quality evidence that knowing your body fat percentage is truly helpful in improving your health. There also wasn’t any evidence presented about how effective it is to measure body fat percentage prior to engaging in a weight loss program in terms of whether it helps people lose weight. The story did not engage in overt disease mongering. In fact, it concluded that having the test is ""not a good idea if the number will be just one more thing to obsess over or feel guilty about."" Both professionals interviewed were from the private commercial sector – one from a center that uses the Bod Pod (hardly an independent voice on the topic) and one who is a book author. The story would have been enhanced with the inclusion of insight from a clear expert in the field of body composition assessment. The story did a very nice job of running through the various techniques for measuring body composition and even included a link to an online calculator of body mass index (BMI). The story explained that body composition measurement with the BOD POD is hard to find because there are few locations with the apparatus. The story accurately portrayed the BOD POD as a piece of equipment that had been around for a while. We can’t be sure if the story relied largely or solely on a news release." Claim: What are you made of? The BOD POD knows all

SOLUTION: This story did a fine job of explaining the various ways body composition can be measured and what the measurement means and how it might be used. But a major shortcoming of the story was that it did not do a good job of providing a critical appraisal of the evidence behind the BOD POD device. Do we really know that it is worthwhile to measure our body fat percentage? At what cost? If it is so beneficial, why doesn’t my health care provider have a BOD POD in the office? What do clinical experts in body composition measurement say about the evidence that the BOD POD is a more useful tool than the body mass index? All unanswered, but important, questions for this story to address. This may be a case where our star ratings are deceptively high.

PROBLEM: Paragraph: There is no mention of the cost of this new drug, Rydapt (midostaurin), or of the cost of the diagnostic tool, the LeukoStrat CDx FLT3 Mutation Assay, which the FDA approved for use in determining the appropriateness of using this drug. Many patients will need to be tested for this mutation in order to find the individuals who have it and thus may benefit from this new drug. However, the FDA evaluates drugs without considering costs, which is why they are not discussed in this news release. Although the release does provide some numerical context, it’s insufficient to give credit here. The release could have provided much more useful information about the quantitative benefits. For example, a summary of the trial upon which the approval was based stated, “At a median follow-up of 57 months, midostaurin reduced mortality risk by 23% compared with placebo plus chemotherapy. The median OS was 74.7 months for the group receiving midostaurin versus 26 months for the placebo group (P = .007), representing a 23% reduction in the risk for death favoring midostaurin.” The release should have provided both absolute as well as relative benefits, both of which were available from the trials. What the release does say is that patients who received a combination of standard chemotherapy and Rydapt for treating AML “lived longer than patients who received chemotherapy alone, although a specific median survival rate could not be reliably estimated,” compared to patients receiving chemotherapy plus a placebo. That’s pretty vague. In addition, it said that “patients who received Rydapt in combination with chemotherapy in the trial went longer (median 8.2 months) without certain complications (failure to achieve complete remission within 60 days of starting treatment, progression of leukemia or death) than patients who received chemotherapy alone (median three months).” The release effectively reports possible side effects experienced by AML patients receiving Rydapt, including “low levels of white blood cells with fever (febrile neutropenia), nausea, inflammation of the mucous membranes (mucositis), vomiting, headache, spots on the skin due to bleeding (petechiae), musculoskeletal pain, nosebleeds (epistaxis), device-related infection, high blood sugar (hyperglycemia) and upper respiratory tract infection.”  It also warns women who are pregnant or breastfeeding to avoid taking Rydapt. It also points out that the FDA approved the use of Rydapt for other patients with “certain types of rare blood disorders” and provides a list of possible side effects they might experience. The release explains that the approval follows the completion of a “randomized trial of 717 patients who had not been treated previously for AML.”  It would have been better if the release would have added how many patients were screened with the diagnostic test to identify the 717 patients studied. While it appears this treatment prolongs survival, it isn’t clear from the release what the time frame is, meaning people may live longer but still may die in the end of the disease. And while the release states that there are almost 20,000 patients diagnosed with AML each year in the US, it doesn’t state how many may have this mutation and thus be potentially treated with this new therapy. According to a review article published last year, “Approximately 30% of patients with AML carry the FLT3 mutation, which is associated with aggressive disease, with poor prognosis and a high risk for relapse.” That means that most patients with AML will not be eligible for this treatment but the release could give the general public the impression that it will help most patients with AML. There is no evidence of disease mongering here. AML is a life-threatening condition and new agents that can prolong life are clearly needed. There’s plenty of context about the disease and how the drug works: “Rydapt is a kinase inhibitor that works by blocking several enzymes that promote cell growth. If the FLT3 mutation is detected in blood or bone marrow samples using the LeukoStrat CDx FLT3 Mutation Assay, the patient may be eligible for treatment with Rydapt in combination with chemotherapy.” The release doesn’t mention who funded the research leading to the approval, although some readers might be able to guess that Novartis Pharmaceuticals, the manufacturer of Rydapt, and Invivoscribe Technologies, the makers of the LeukoStrat CDx FLT3 Mutation Assay, sponsored the trials since the approval was given to them. The new medication was used in combination with standard chemotherapy. That tells us the alternative was standard chemotherapy alone, an important comparison. While the release doesn’t specifically state the availability of the drug, the FDA approval for its use suggests that it should start to become available in a matter of months and not years. The release makes clear that the use of this drug for AML patients with the FLT3 mutation is a new approach for a situation where previous therapies have been marginally successful. It also claims that the drug is “the first targeted therapy to treat patients with AML, in combination with chemotherapy,” according to an FDA official. No unjustifiable language here. Claim: FDA approves new combination treatment for acute myeloid leukemia

SOLUTION:
acute myeloid leukemia (AML) This release from the Food and Drug Administration announces approval of a new drug, Rydapt (midostaurin), for the treatment of specific acute myeloid leukemia patients who possess certain genetic FLT3 mutations that affect the immune system. It points out that when these patients are identified through the use of a specific test — the LeukoStrat CDx FLT3 Mutation Assay — then the new drug can be used along with standard chemotherapy until remission and then as a maintenance drug following that. The descriptions surrounding the benefits of the drug and the evidence are vague. It would have been good to see both absolute and relative benefits included in the release, and a clarification that only about one-third of AML patients will be candidates for this drug treatment. While there is no mention of the cost of the drug or the test (which FDA releases seldom include), the release provides clear information on harms and how the drug works. Acute myeloid leukemia (AML) is a serious and often fatal form of blood cancer, and treatments against it have been limited in the past. AML involves the cells that fight infection in the body. Increased understanding of the genetics of this disease has identified a large number of genetic mutations associated with the development of AML. This study examines patients with one type of mutation, FLT3. Though not stated in the release, it is estimated that around 30% of patients with AML will have this mutation. While this represents a sizable number of individuals, it is important to acknowledge that most patients diagnosed with AML will not have this mutation and therefore won’t be treated with midostaurin. As the release points out, “the National Cancer Institute estimated that approximately 19,930 people would be diagnosed with AML in 2016 and 10,430 were projected to die of the disease.”  The situation is worse for those AML patients who possess the FLT3 mutations so this new approach might give both physicians and patients a new alternative treatment.