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.

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
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.

Paragraph: Scientists at Vienna University medical school’s Institute of Hygiene and Applied Immunology came to the conclusion after analyzing the water quality at 21 “holy” springs and 18 fonts at churches and chapels at various times of year. Only 14 percent of the water samples from holy sources showed no fecal contamination, and none of the springs could be recommended as a source of drinking water, the study presented to a conference in Vienna this week found. The springs held not only fecal contamination - likely the result of poor hygiene - but many also had agricultural nitrates and bugs that can cause inflammatory diarrhoea. “We need to warn people against drinking from these sources,” microbiologist Alexander Kirschner said in the study. Kirschner said the healing effects ascribed to holy sources arose from the hygienic conditions of the Middle Ages, when water quality in urban areas was generally so poor that people constantly contracted diarrhoea or other conditions. “If they then came across a protected spring in the forest that was not as polluted and drank from it for several days, their symptoms would disappear. So although in those days they were drinking healthier water, given the excellent quality of our drinking water today, the situation is now completely reversed.”  The study noted some ways to help address the problem, including regularly replacing holy water in church fonts. One Italian priest has invented a holy water dispenser that dispenses drops of holy water rather than having the faithful dip a hand in, it noted. Claim: Holy water in Austria unsafe to drink: researchers.
Holy water at religious shrines and churches in Austria is often contaminated with fecal matter and bacteria, researchers have found, advising the faithful not to drink it, especially in hospital chapels.

Paragraph: The story mentioned that the cost of this drug treatment was several thousand dollars a month and that this was higher than the costs of other treatments. It would have been better to provide a more concrete estimate of costs (several thousand – does this mean 2,3 or 6 thousand?). The story might have included some information about additional costs that would be encountered with the comparison treatment such as the cost of intraveneous infusions, testing to  evaluate side-effects, and other connected costs. The story did a good job reporting the data comparing patient survival with Iressa as compared to individuals treated with IV chemotherapy. The story skimmed over the side effects; reducing the frequency of bothersome or life threatening side effects would seem to be an advantage. The story mentioned quality of life factors that appear to be better with Iressa but did not  quantify the benefit observed. Borderline satisfactory. The story listed the common side effects of the treatment though it failed to indicate the frequency with which these were seen. In addition, rather than than merely listing these, the story could have included some information about the severity of the side effects (i.e. bothersome vs. fatal). The story provided information about the size of the study conducted, the nature of the patients that were enrolled, and that the drug company that markets the drug funded the study. The study was designed as a non-inferiority survival trial to compare this medication with docotaxel, a chemotherapy treatment often used in individuals who have lung cancer and have had platinum based treatment but who are experiencing a return of their cancer. (While the story did provide information about the survival outcomes, it also included information comparing side effects.) The story ended with a comment from one of the interviewed clinicians about quality of life being better with Iressa. The story should have been clearer about the predetermined endpoint of the study (longevity) and should not have ended with less data driven information. The story did not engage in overt disease mongering. However the headline does not hint that the trial is not about first-line cancer treatment, rather just patients who have been treated previously with a platinum-based chemotherapy. The story included quotes from two individuals identified as not being connected with the study reported upon but with relevant expertise. The story provided information about two treatment options for individuals who have recurrence of a previously treated lung cancer. It did not provide information about the natural history of not undergoing additional treatment for this condition which is necessary for evaluating the relative merit of the two treatments discussed. The story did not mention radiation and surgery which are both options for some limited cancers. The story mentions that the medication Iressa (gefitinib) is sold in the United States but that its availability in Europe is limited. The story presented the use of Iressa as a treatment of individuals with lung cancer who had previously been treated with a platinum-based regimen as though it was a novel application. However – this drug was approved by the FDA in 2003 for this purpose. While the results of study reported on are interesting, the story did not provide the reader with a realistic picture of about the novelty of this product. Does not appear to rely on a press release. Claim: Pill as good as chemo on lung cancer, but costlier

This was a concise (only 430-word) story reporting on the outcomes of a recent study which compared outcomes for patients with lung cancer who had previously undergone platinum-based treatments and received either the oral medication Iressa or chemotherapy infusions. It shows how efficiently critical elements can be relayed by a thoughtful reporter: the skeleton of study design, the bias implied by the funding source, the results, along with the comments from experts. While the piece did a good job describing the study it was reporting on, it could have done a better job of putting the study into the perspective about what is already known about the medication Iressa. And while the headline did the story a disservice in that this treatment is not appropriate for all persons with lung cancer, this was a generally informative piece that a reader with a previously treated lung cancer would find useful for initiating a conversation with their physician.