instruction:
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.
question:
The news release does not mention costs. While a new therapy may not have an established price, the release could have stated “no price is available for this drug.” What would be even better is some context for what women suffering from postpartum pay typically for counseling and medications. The release notes that  there was a reduction in depressive symptoms of 17 points for those on the drug, and 12.8 for those in the placebo group based on the Hamilton Depression Rating Scale. The absolute reduction in the rating scale is given for each group. This information would have been much more helpful if the release also clarified the magnitude of the scale and whether a 4.2-point difference is clinically meaningful. The release contains one somewhat vague sentence on harms. The most common (≥10% of subjects) adverse events following during brexanolone injection administration were headache, dizziness and somnolence. Readers would also be interested in details on whether the drug is safe for nursing infants. That’s not mentioned. The double-blinded randomized trials are described in detail and readers are able to judge the quality of the evidence. The published study includes an important limitation of the research that’s not mentioned in the release: The trials assessed women for only 30 days; the effects of the treatment beyond 30 days are “unknown.” There is no disease mongering. The release explains how common postpartum depression is worldwide. The release notes that Sage Therapeutics funded the research. Sage Therapeutics is the developer of brexanolone injection and sponsor of the trials. A New Drug Application is currently under review by the FDA and brexanolone injection has been granted Breakthrough Therapy Designation. The FDA has assigned a Prescription Drug User Fee Act target date of December 19, 2018. What the release doesn’t tell us is that both quoted researchers disclosed financial ties with Sage Therapeutics. This information was included in the studies published in the Lancet. SM-B reports personal fees from MedScape and grants from Sage Therapeutics, awarded to the University of North Carolina … DRR reports personal fees and has stock options in Sage Therapeutics…. The release mentions that women currently can receive antidepressants for postpartum depression, but that the new drug being studied goes to work relieving symptoms faster than traditional antidepressants — days rather than weeks. The release notes that the drug is currently under FDA review, with a decision on its approval expected by the end of the year. The release notes that the new drug would be a novel treatment for postpartum depression, if approved. There is no unjustifiable language.
answer:
Newly Published Results Show Investigational Treatment Brexanolone Consistently Reduced Depressive Symptoms Across Three Postpartum Depression Trials, Supporting Submission for FDA Approval


question:
The story sidebar estimates that a full course of treatment can cost $3000 or more. It could have added that this treatment is unlikely to be covered by many insurance companies. This was the biggest hole in an otherwise reasonably solid story. The article claims that there is “growing evidence” that neurofeedback can help treat people with ADHD. However, the story never describes any of the results of this purported increase in research that supposedly documents these benefits. The closest we come is the description of a study which hasn’t even been published yet. The story also suggests that neurofeedback’s benefits might last longer than those of medication. Again, however, we are never given any sound basis to believe that neurofeedback works at all — let alone better than other treatments. At the same time, the story leans heavily on testimony from a journalist who has written a book about ADHD and claims neurofeedback worked for her and her son. We are told that the primary improvement she saw with her son was that he was “easier to live with.” Although this kind of anecdotal report can be useful to add context to scientific findings, it is certainly no substitute for reporting on the actual clinical outcomes of research. The story failed to discuss any potential harms of neurofeedback treatment. The most prominent of these is that patients could forego other treatment approaches that have better supporting evidence and are more likely to reduce symptoms. There is also some evidence that neurofeedback can cause seizures or make symptoms worse in some individuals with psychological disorders. In addition, the need for frequent treatments may necessitate taking a child out of school. Readers should come away from this story with a generally accurate feel for where the research on this treatment stands. The story told readers early on that neurofeedback is “scientifically uNPRoved” for the treatment of ADHD. It backs up this contention later in this story by noting that almost all research on this treatment hasn’t involved a placebo control group. And the only study to include such a group apparently hasn’t released its results yet and seems to have involved a very small number of patients. In addition, the story quotes an expert who emphasizes that other forms of treatment (e.g. medication and behavior therapy) have better evidence to support their effectiveness for ADHD. We did think the story focused a bit too much on a single patient anecdote (a deficiency discussed later under the “Benefits” criterion) — an emphasis which makes the treatment sound very promising with little justification. The story could have struck a better balance by toning this section down a bit. No disease-mongering in this story. In addition to extensive comments from the journalist book author who discusses her experience with neurofeedback, the story quotes a Duke University researcher who is an expert on ADHD and offers some counterbalancing perspective. The story quotes a researcher who says that two other approaches — medication and behavior therapy — have a more extensive research base supporting their use for ADHD compared with neurofeedback. It’s clear from the story that this type of treatment is available to the general public. We like that the story cautioned readers to look out for unqualified therapists and gave tips for finding reputable clinicians. The story could have been more specific about how many trained professionals there are and how easy it is to find them outside of large population centers. The story does not oversell the novelty of neurofeedback for the treatment of ADHD. This story does not appear to be based on a news release.
answer:
Train The Brain: Using Neurofeedback To Treat ADHD


question:
"The article includes price information for the drug’s likely competitor, Plavix–about $4 per day, a significant cost for a drug that is taken daily, perhaps for a lifetime. The article correctly indicates that the price of Plavix is likely to come down when it goes generic in four years. The article properly includes speculation that the pricing of prasugrel may be a key factor in its adoption, should it be approved. The reporter includes considerable data about several key clinical endpoints of both benefits and harms, in two cases using both absolute numbers of patients and percentage increase or descrease. The reporter gets extra points for including ""number needed to treat""–the number of people who would have  clinically significant outcomes for each 1,000 treated with the drug. The story is built around the question of the drugs’ risks vs. benefits. Data about harms are mentioned early and often, and described in detail. A direct comparision of the fatal bleeding rates for the two drugs would have been additionally useful. The New England Journal of Medicine article is based on results of a Phase III trial that appears to meet all the important criteria for significance: the study is prospective, the study group is large, the patients were randomized, the treatments double-blinded, the clinical endpoints signficant. While there is no placebo group, this was likely decided for ethical reasons, so all patients in the study would receive at least current best-practice treatment. The article assigns proper crediblity to the study, which to appear in NEJM has received rigorous peer review. The article does nothing to exaggerate the risk of death or the consequences of heart attacks, strokes or cardiovascular disease deaths. It allows the outcome figures to speak for themselves. The article quotes five experts in cardiology from different institutions, providing greater balance and context than just one or two experts would. In each case the relationship of the souce to the study and/or its funders is revealed. The considerable conflicts of interest of the investigators are made very clear. The article makes clear that prasugrel is being developed as an option to Plavix, and that Plavix with aspirin is currently best-practice treatment. The article makes clear that the drug prasugrel is not FDA approved and that its approval is uncertain. The article makes clear that this is a drug that is very similar to Plavix, and that it may be marginally more effective. No claims of novelty are made. The companies’ joint press release, an enthusiastic announcement about the drug’s benefits, bears little resemblance to this story."
answer:

Blood drug trades benefit for risk