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.
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Question: 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

Answer: 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.


Question: Paragraph: "Bounciest Democrat on November's statewide ballot? It might be Hank Gilbert, making his second hard charge for state agriculture commissioner versus Todd Staples, the Republican who topped him four years ago. Gilbert, ever prowling for issues, recently trumpeted that the Texas Department of Agriculture is looking at buying thousands of stress balls -- squeezable toys. He said in a Sept. 24 press release: ""Make no mistake, Texans love their balls: footballs, baseballs, basketballs, and soccer balls. But 300,000 stress balls? It seems a little extreme, but that's the quantity of grape, barbell, and book-shaped polyurethane stress balls the Texas Department of Agriculture could be spending taxpayer dollars on...""  Really? To our inquiry, Gilbert's campaign provided Web links to the agriculture agency's June request for bids as well as a September post on a state website indicating that a $99,000 contract to provide promotional materials was awarded to a Massachusetts company, Oceans Promotions. We downloaded the June 29 bid-request package from a site for state requisitions overseen by the state comptroller's office. The package shows the department was seeking bids to provide up to 300,000 stress ""relievers,"" which we're guessing are not balls because they're not round. Precisely, the package says, the agency sought bids to make ""promotional items with logo imprints to follow through on (the) TDA Food and Nutrition Texans Bring It Campaign,"" with the items to include grape-shaped stress relievers with ""Texans Bring It"" written on them or ""Eating Right,"" which would be made of polyurethane and be two inches high by three inches wide. The package says a second set of stress relievers, each one called ""Dumbbell,"" would be imprinted ""Texans Bring It"" and ""Exercise"" and be five inches high by 1.8 inches in diameter. A third stress reliever would be imprinted ""Book"" and ""Texans Bring It,"" according to the bid package, while other promotional items would include pencils, buttons and bumperstickers. The package says the bids were sought for various quantities, starting from 2,500 and topping out at 100,000 each. It electronically links to a Branders.com site showing what the agency wanted the stress relievers to look like (our interpretation: bunches of purple grapes). Is all this a real deal? To our inquiry, Bryan Black, Staples' spokesman, replied via e-mail: ""An invitation for bid was issued for these federally funded educational items to reduce the $5.8 billion avoidable health care expenditures, paid by taxpayers, associated with overweight and obesity health problems."" We followed up with Black, asking if it's accurate to conclude that up to 300,000 of the stress relievers are being purchased. We also wondered why the purchase was being made. Black said he'd limit his comment to his e-mailed statement. Surely the agency would pipe up if Gilbert got its purchase plans wrong." Claim: Hank Gilbert Says the Texas Department of Agriculture seeks to purchase up to 300,000 promotional stress balls.

Answer: Hank Gilbert says Texas Department of Agriculture could be buying up to 300,000 stress balls


Question: Paragraph: This infection rate was higher even in the year before the men got their prescriptions filled, which suggests the risky behavior came first, the researchers reported in the Annals of Internal Medicine. The study shows that even middle-aged men need advice about spreading and catching STDs, especially AIDS, which is deadly and incurable, Dr. Anupam Jena of Harvard Medical School in Boston and colleagues wrote. “Users of ED (erectile dysfunction) drugs had higher rates of HIV, chlamydia, gonorrhea and syphilis in the 12 months before filling their first ED drug prescription, although only HIV and chlamydia were statistically significant in this period,” Jena’s team wrote. “At a minimum, use of ED drugs seems to correlate with higher-risk sexual behavior, either in the number or type of sexual encounters.”   Jena and colleagues looked at the health insurance records of 33,968 men with at least one prescription for an ED drug and more than 1 million men without a prescription, searching billing codes for STDs. Rates of HIV per 100,000 men in the previous year were 66.5 for men who did not get an ED drug but 147.2 for men who did. Rates of chlamydia where almost triple for men who took an ED drug — 41 per 100,000 compared to 15 per 100,000 for men not using the drugs. Erectile dysfunction drugs are popular and include Pfizer’s Viagra, known generically as sildenafil, vardenafil, sold under the brand name Levitra by GlaxoSmithKline and Eli Lilly and Co’s Cialis, known generically as tadalafil. They all belong to a class called phosphodiesterase-5 inhibitors and they work by increasing blood flow. As many as 40 percent of men aged 57 to 85 have some degree of erectile dysfunction, editors of the journal wrote in a summary of the findings. Dr. Thomas Fekete of Temple University School of Medicine in Philadelphia said the study “reminds us that men older than 40 years remain sexually active, even if they need chemical assistance to do so.”   “There has been concern that these phosphodiesterase-5 inhibitors have become ‘lifestyle’ drugs used to intensify sexual pleasure, even in men without ED,” Fekete wrote in a commentary. The study was unable to document why the men got the drugs and also would not account for men who may have bought such drugs over the Internet. Fekete found something else puzzling. “If the estimated rate of ED in men older than 40 years was 20 percent to 40 percent, it seems surprising that less than 7 percent of these men with insurance coverage received prescriptions for ED drugs,” he wrote. “This implies that despite sexual dysfunction, at least one third of men were either satisfied with their sex lives or obtained ED drugs through other channels (for example, Internet pharmacies),” he added. The study found that in 2006, 3.6 percent of men over 40 used Viagra, 1.7 percent used Cialis and 1 percent Levitra. Claim: Men taking drugs for sex function risk sex diseases.

Answer:
Men who took erectile dysfunction drugs such as Viagra were more likely to become infected with sexually transmitted diseases, including AIDS, U.S. researchers reported on Monday.