TASK DEFINITION: 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.
PROBLEM: Paragraph: We’ll give the story the benefit of the doubt for again leaning on an independent expert who says the technology is likely prohibitively expensive. While no dollar estimate is given, we think this is good enough for now. As with the harms, the story does quantify the benefits in one way. It says, “It could help avoid up to 98% of these screening procedures, according to the study, which appears in BMJ.” It also says, “The new study included 753 pregnant women who were at high risk for having a child with Down syndrome. Of these, 86 women were determined to be pregnant with a child with Down syndrome.” The story does quantify potential harms in one way by noting, “There were no false-negative results with the new test.” We wish the story also spoke about false positives. False positives are certainly part of the stress and harms from any screening test that need to be considered. In this case, it appears the false positives were low but not negligible. The story adequately describes the study design. The story does avoid disease monitoring, but we wish it had included some of the data from the paper about the frequency of Down syndrome and even some of the other disorders. The LA Times blog piece managed to do this in much less space. The story provides a wealth of outside experts who provide great commentary and context about the study’s findings. We wish more stories about screenings had quotes like these: “In a year or two, this test may be available, but it won’t replace existing technologies, it will nudge its way into our armamentarium of available methodologies,” says Mark I. Evans, MD,  director of Comprehensive Genetics in New York City, and an obstetrician/gynecologist at Mount Sinai School of Medicine, also in New York City. “The bad news is that prenatal diagnosis is not just about Down syndrome…Down syndrome represents about 50% of what we find, and this new test can help with that, but it may also give women a false sense of reassurance.” The story tries to do a good thing by explaining at the very end that the new test is not a diagnostic test, as amniocentesis and chorionic villus sampling are. Rather, it’s a screening test. The distinction – and the significance of that – could have been made more clearly, but we give the story the benefit of the doubt. The story leans on an independent expert to say that the test is “not ready for prime time….in a year or two, this test may be available.” The story does not establish the test’s novelty, and this is largely because it does not provide the proper context. The study itself says, “In the past 20 years maternal age has been combined with ultrasonographic examination of the fetus and biochemical measurement of various proteins or hormones in the maternal circulation to improve identification of high risk pregnancies. This combined approach of screening can now identify more than 90% of affected fetuses, but there is still a need for invasive testing in 3–5% of the population.” This means that as many as 95% of all women would not need invasive testing to begin with, so this test is only potentially a breakthrough for a small minority of women. BMJ actually makes the novelty question easy to answer by breaking it down this way:  What is already known on this topic: Non-invasive prenatal detection of fetal trisomy 21 is achievable by massively parallel sequencing of maternal plasma DNA Its diagnostic performance and practical feasibility in the clinical setting has not been tested on a large scale. What this study adds: Among high risk pregnancies clinically indicated for invasive prenatal diagnosis, non-invasive detection of fetal trisomy 21 can be achieved with the use of multiplexed massively parallel sequencing of maternal plasma DNA at 100% sensitivity and 97.9% specificity, giving a 96.6% positive predictive value and 100% negative predictive value. The sequencing test could be used to rule out trisomy 21 among high risk pregnancies before proceeding to invasive diagnostic testing to reduce the number of cases requiring amniocentesis or chorionic villus sampling.” The story does not rely on a news release. Claim: Progress Toward Blood Test for Down Syndrome

SOLUTION: This thoroughly reported and carefully written story avoids giving pregnant women false hope of an easier way to detect genetic anomalies while still presenting some compelling information about a new blood test. Pregnancy can be anxiety inducing because of the sheer number of tests already required of women: frequent blood tests, ultrasounds, and amniocentesis in many cases. Add to that the barrage of stories about the way diet and environmental conditions may be affecting in utero development at any given point and one can understand why women might want a simpler solution to find out whether their child might have a genetic disorder. Overall, we think if more stories approached screening the way this story did there would be fewer people demanding the latest over-hyped test from their doctor. This is a “hope for the future” level test that may be inching its way to market. It’s not available now and won’t be in the immediate future – and the story makes that clear.

PROBLEM: 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

SOLUTION: 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.

PROBLEM: Paragraph: Add Serena Williams to the list. The 23-time Grand Slam champion playing in the U.S. Open took to Instagram last month after a loss in San Jose, California, to describe her feelings of inadequacy as a mother since the birth nearly a year ago of her daughter, Alexis Olympia Ohanian Jr. “Talking things through with my mom, my sisters, my friends let me know that my feelings are totally normal,” she wrote. Postpartum depression, or PPD, does not have a single cause, according to the National Institute of Mental Health. It likely results from a mix of physical and emotional factors. The condition can last up three years after giving birth, with symptoms ranging from feelings of sadness beyond the “baby blues” to thoughts of self-harm or doing harm to the baby. According to the American Psychological Association, up to 1 in 7 women experience the serious mood disorder or worse after giving birth. The World Health Organization says about 20 percent of mothers in developing countries around the globe experience clinical depression after childbirth. Though public discourse on postpartum depression has never been higher, a stigma persists. Friends, co-workers and loved ones who haven’t experienced depression themselves may be at a loss for how to help. “I think people are scared to talk about it, but many people suffer and want to know they are not alone,” said Talya Knable, a Baltimore counselor with friends and clients who struggled. “People need a lot of support.” When it comes to attempting that support, she said, there are sentiments to avoid: “Everyone has a hard time, you will get used to it. I didn’t feel depressed when I had a baby. It can’t be that bad. You don’t need medication to get through this. Don’t you love your baby? This is what you always wanted, you should be happy!” Developing a more positive vocabulary when looking from the outside in is a matter of reassurance, Knable said: “You are a great mother and doing a great job. This part is really hard. It will get better. You are not alone in this. I am here to help if you need me. I know you are trying really hard. You can do this!” Amanda Munday in Toronto suffered from severe postpartum depression and was hospitalized for 18 days following the birth of her first child, a daughter who is now 4. Her list of what not to say includes: “Is the baby healthy, though? Sleep when the baby sleeps” and “It’s just your hormones, it will pass.” She suggests reaching out instead with: “You are a good parent. Those dark thoughts do not define you” and “You are allowed to put yourself first.” Heidi McBain is a Flower Mound, Texas, therapist who specializes in maternal mental health. She struggled with postpartum anxiety herself after a miscarriage and went into therapy for grief and loss when she got pregnant again. The anxiety continued after the birth of her son, who is now 9. Her what-to-say list is short and to the point: “How can I help?” Her do-not-utter list covers some common missteps: “Why would you need medication from your doctor? Are you sure this isn’t all in your head?” Seeing a doctor is precisely what a woman should do if she fears the “baby blues” have crossed into more dangerous territory, according to the National Institute of Mental Health. The term “baby blues” is often used to describe “feelings of worry, unhappiness and fatigue that many women experience after having a baby,” the agency said. Up to 80 percent of mothers experience such feelings in a somewhat mild form, lasting a week or two and going away on their own. Postpartum depression is when sadness and anxiety can be extreme and interfere with a woman’s ability to care for herself or her family, the institute said. It usually requires treatment. “Finding a therapist who specialized in postpartum mood disorder and the right medication under supervision of a psychiatrist is what helped me get better. It’s an illness that needs professional treatment,” said Jen Schwartz, co-founder of the blog motherhood-understood.com. Getting out of the house as a new mother suffering severe PPD can be a problem, said Carole Brody Fleet in Orange County, California. She suffered after the birth of her now 29-year-old daughter, at a time when fewer women were willing to speak out. Finding it difficult to leave the house, she received over-the-phone counseling from La Leche League. “The most important step for me in treating PPD was understanding that reaching out for help was not a sign of weakness or failure as a new mother,” she said. Dr. Adeeti Gupta, who founded Walk In GYN Care with two clinics in New York, has one sentence that loved ones should never let slip out: “Are you depressed and unhappy about being a mother?” Claim: Know what to say when postpartum depression hits a loved one.

SOLUTION:
Gwyneth Paltrow, Chrissy Teigen, Adele: The charge to destigmatize postpartum depression has never before had so many high-profile sufferers willing to share their stories.