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.

Q: 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.

A: Newly Published Results Show Investigational Treatment Brexanolone Consistently Reduced Depressive Symptoms Across Three Postpartum Depression Trials, Supporting Submission for FDA Approval
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Q: The story reports not only the cost of the blood test ($60), but the cost to detect one case (including follow-up), which the researchers calculated to be $28,600. This is excellent context. The story would have been better if it had noted that the people included in this study were at unusually high risk for developing this cancer. The 34 cases found after screening 20,000 people is almost 200 times the typical annual rate in the US and other countries (less than 1 per 100,000 people per year). The ultimate measure of cost is cost-effectiveness (cost per life-year saved) which requires survival data. These analyses can also be adjusted for quality of life. While most of this story is careful to note that this test has yet to show clinical effectiveness, that caution is trampled by the claim that this blood test “boosted patients’ chances of survival,” something that this type of study cannot determine. The claim that this test is more accurate than existing methods is also premature, since the study did not directly compare the blood test to existing methods. Finding more early-stage cancers is a necessary but hardly sufficient step in the pathway of demonstrating benefit for a new screening test. Clinical trials are needed to address issues of false positives, over diagnosis, over treatment, and survival. The story reports that developers of this blood test still need to show low rates of false positive or negative results. A low false negative rate means there are fewer missed cases of serious disease. The trade-off, though, is a higher false positive rate. All positive tests will need to be evaluated with a gold standard diagnostic test and the safety, acceptability, and costs of that gold standard test will profoundly affect the uptake of the new screening test. While the story reports that this study was a “proof-of-concept” experiment, it then says the test boosted survival, something that can only be known after directly comparing the new test to existing methods. Making treatment “dramatically more effective” can be proven only with randomized trials. All screening tests that can detect cancers at an earlier stage will be associated with an apparent increase in survival time, but as explained in more detail below, this does not necessarily mean that patients with screen-detected cancers actually live longer than they would have otherwise. Efficacy can be established only with an RCT. The story could have done a better job pointing out the many limitations in the work. For example, there was no follow-up testing for people who had negative blood test results. Even though the researchers surveyed participants a year after the testing, they didn’t produce any data on how many of the people with negative blood tests actually had cancer. What’s more, the researchers compared the survival rates of their patients to a different group of cancer patients from another study, which raises questions about how comparable the groups really are. There was also no discussion of the possibility that at least some of the tumors discovered through this screening might not have developed into dangerous cancers. The story does not address lead-time bias (that longer survival might be at least partly due to finding the tumor earlier in its natural course, rather than to just the effect of treatment). The researchers noted that the effect of lead time bias can only really be known through a randomized, controlled trial. We will rate the story satisfactory on this criterion because it is careful to note that this test is not ready for clinical use and that the study results apply to only one type of cancer. However, the story would have been better if it had pointed out just how rare this cancer is, less than one case per 100,000 people in the US per year. That is about 3,000 cases in the US per year — out of about 1.7 million cancers diagnosed annually. And the comment that the cancer “is prevalent” in southern China and Southeast Asia may be misleading. While it may occur more often in the region, rates are still on the order of 10 to 20 per 100,000 which is hardly widespread. The story squeaks by on this criterion because it includes a quote from an editorial in the journal that was written by an independent source. It would have been more useful to readers to include more comment and context from someone without financial ties to this study. The story is upfront about the financial interests of the researchers themselves and the company that owns the rights to their work, noting the keen interest in bringing this test to market. Although the story reports that “that nasopharyngeal carcinoma typically goes undetected until later on, when patients report symptoms such as recurring nosebleeds,” it does not tell readers anything about how often these cancers are found at an early stage. Readers are not given a sense of how patients typically fare with existing methods of diagnosis. The story clearly reports that the test is still experimental and that developers have yet to show that it could be practical and effective in clinical practice. The story highlights the desire for a new blood test that could be clinically useful. The story doesn’t appear to rely on a news release. It includes quotes from a telephone interview with an executive at the company developing this test.

A: Silicon Valley Startup Grail Sees Hope for Cancer Blood Test
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Q: The Georgia Department of Public Health said Friday at least two of the three new measles patients in Cobb County are not vaccinated. All three are part of the same family. Tests are under way to determine if yet one more person is infected. Cobb County school district officials said Monday that a student at Mabry Middle School in Marietta had measles. State health officials said it’s highly likely all the Cobb County cases are related, but they are still investigating. Measles is highly contagious. The U.S. has experienced a resurgence of the illness that’s fueled by outbreaks in unvaccinated communities.

A:
3 more measles cases confirmed in Georgia county.
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