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.

Example 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
Example 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.

Example Input: Paragraph: The story notes the price “per squat” at various spas and the cost of a do-it-yourself Internet kit. We think the story’s discussion of possible benefits is far too extensive considering the total lack of evidence to support them. We understand the need to identify some of the claims made by boosters of the therapy, but the story devotes some three paragraphs to seemingly every possible ailment the baths (or the herbs used in them) are purported to treat. It also throws in an anecdote from a woman suggesting the baths helped her to conceive at the age of 45. The caveats about chai-yok stand a good chance of getting lost in this avalanche of discussion about benefits. Aside from burns — the potential for which would seem to be obvious — we’re not sure if there are any harms associated with herbal steam baths for the vagina. The procedure seems less invasive than a douche, which is associated with potential health risks. We’ll call this not applicable. The story states that there are no studies that document the effectiveness of chai-yok for any of the conditions it is claimed to treat. It notes that while there is some biological rationale for why heat in the perineal area might be beneficial, it is impossible to say whether these steam baths do any good. The concept behind chai-yok seems vaguely reminiscent of douching, a treatment that has long been promoted as necessary for vaginal health despite a lack of supporting evidence and indications of possible harm. But while the idea may tap into some of the same psychology that makes the normal vagina seem not quite clean or healthy enough, we don’t see any evidence of overt disease-mongering in this particular story. The story quotes two doctors with expertise in gynecology and fertility. It also solicits comments from a practitioner of traditional oriental medicine. We don’t think the story had to mention alternative treatments for all the myriad problems that chai yok can supposedly help with. But since the story suggests in several places that chai yok increases fertility, we think a brief mention of other approaches that are supported by medical evidence would have been appropriate in this case. The story didn’t provide this information. The story identifies several spas in Los Angeles and New York where vaginal steam baths are offered. It notes that the treatments “are not easy to find” across the country. The story acknowledges the roots of chai-yok in Korean medicine.The approach is described as extremely avant garde in the U.S. — a characterization which is probably accurate. Given the variety of sources quoted, we can be sure the story wasn’t based on a press release. Claim: Vaginal steam bath finds a place among Southern California spa options
Example Output: We liked that this story points out early on that there is zero evidence to support the health benefits of herbal steam baths for the vagina, which are known in traditional Korean medicine as chai-yok. But we became confused when the story explained that the treatment is almost totally unheard of in the U.S., even among gynecologists and fertility experts. If there’s no evidence that chai-yok works and almost nobody knows about it or has tried it, what exactly makes this treatment worthy of an 850-word article in a leading national newspaper? There are limited journalistic resources to cover the seemingly limitless number of treatments that are out there. So we’d prefer to see journalists pursuing stories that aid the decision-making of a significant number of health care consumers. A story about herbal steam baths for the vagina seems unlikely to meet this objective.

Example Input: Paragraph: While the news release says the research is aimed at lowering costs and reducing the burden for low income patients, we are not given any numbers that describes the value of the intervention. The release only gets as detailed on cost as the excerpts below: The findings, which support earlier research demonstrating positive results of the assessment and treatment method in a university setting, have the potential to transform dental care for high-risk patients at a lower cost to both patients and dental clinics and practices. Results appear online Jan. 22, 2018, in Advances in Dental Research. The authors said now that this has been shown to be effective in a non-academic clinical setting, there also is potential for insurance companies to reimburse CAMBRA and other preventive therapies for adults, thereby lowering patient costs while increasing profits for dental practices. The release also doesn’t address the cost of prescription fluoride toothpaste which may actually result in higher costs overall. The number needed to treat was 4, meaning that you would have to treat 4 people for one additional person to get benefit. This results in the cost of therapy being multiplied by 4 to get the effect found in the study. The release described benefits this way: Among 242 patients (137 intervention, 105 control) initially identified as high risk for caries, only a quarter of the patients remained at high risk in the CAMBRA group at 24 months, while just over half (54 percent) of the control group did. Of the 192 low-risk participants (93 intervention, 99 control), most participants remained low risk. As noted under Evidence criteria below, the release listed as a limitation the fact that only about one-third of the patients who started the study completed the 24 month checkup. There is no mention of harms. We are given enough information to judge the quality of the evidence; it was a randomized study with an experimental and a control group. The release also deserves praise for noting study limitations, including the high study attrition rate (65 percent of volunteers dropped out before their 24 month follow-up). The study quality seems to have been very good considering the difficulty in performing this type of community based study. The blinding was adequate and although the published study states that the blinding was “double” (patient and investigator), it also appears that the treating dentists (participating treaters) were also blinded to the group that the patient was assigned. This could have been mentioned, too, and would have strengthened the release. There is no disease mongering. The funding sources are listed, and there are no apparent conflicts. In the strictest possible way, the release does not directly talk about all the different ways of preventing dental caries. But we were glad that the release discussed the improvements that happened for some patients in the control group who received fewer products. We are glad the release talks about possibly following up on this, in case the lesser products could still benefit many patients. Excerpt: The researchers said the risk reduction among the control group may have been caused by the fluoride toothpaste enhancing tooth repair, as well as the mouth rinse enhancing saliva flow and having bactericidal effects. While not as significant as the CAMBRA group in this study, the risk level of these patients dropped more dramatically over time than for those in the 2012 UCSF CAMBRA study. It was surprising to see the benefits gained by the control group,” Rechmann said. “More research is needed to see if the products and treatment administered to this group function in the way we speculate, and if so, they might be made easily available to dental patients. Doing so can change the whole picture of caries control. This CAMBRA method is available at about half of US schools and colleges of dentistry according to the release. However, the prescription fluoride toothpaste is available from most pharmacies. The release clearly explains that this research began in 2002, and small incremental steps in its validation have been published over many years. This is one more step. There is no unjustifiable language. Claim: Cavity prevention approach effectively reduces tooth decay
Example Output:
In a study of 460 patients at high risk of dental damage separated into two groups, those who used cavity-prevention products dramatically reduced their risk of cavities compared to the control group, according to researchers at the University of California, San Francisco. The system of prevention is known by the acronym CAMBRA, for Caries Management By Risk Assessment. It included giving the patients prescription fluoride toothpaste, chlorhexidine antibacterial rinse, xylitol mints and fluoride varnish. The release fell short in describing the potential cost saving and addressing any potential for harms. Dental problems are a plague to people of all income ranges and ages. The cost of dental care, where insurance is inadequate or out-of-reach, is a particular burden for low income people. If specific preventive measures are proven to significantly reduce cavities it could benefit many.