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: The story does not mention the cost of mammography (or of follow up tests and treatments) to the individual, or, collectively, to society. And these costs are substantial. Based on the results of this study, 2,500 women would have to be screened every other year for a decade in order to prevent one death from breast cancer. As the story points out, during that same time 1,000 of those women would have at least one false alarm and 500 would undergo an unnecessary biopsy, thus adding to the price tag. On balance, this story does a fair job of describing the benefits of screening mammography as seen in this study. It reports the apparent 10 percent reduction in breast cancer deaths, while also pointing out that because relatively few women in the 50-69 age group die of breast cancer, that reduction can also be described as cutting the 10-year risk of death from 4.4 per 1,000 women to 4 per 1,000. The second statistic helps counteract popular assumptions about how many middle-aged women die from breast cancer. However, the framing of a story – and who gets the last word – sometimes overwhelms evidence-based explanations earlier in the story. That almost happened with this story, which gives the final word to an advocate of annual breast cancer screening for all women beginning by age 40, which is just the sort of blanket recommendation this latest study calls into question. The story includes a comment that because mammograms detect lumps that would not have become life-threatening, five to 15 women may be treated for every one whose life is saved by treatment. The story oversimplifies the methods used by researchers, saying they compared “women who were similar in most ways, except that one group received mammograms and the other didn’t,” without explaining that this was not a randomized trial where some women were assigned to screening and others weren’t, but rather an observational study that looked at data on women during a 9-year period when Norway phased in mammography region by region. The story does alert readers to some of the limitations of the study: one, that a longer follow-up period might have shown more benefit to screening and, two, that the researchers had no information on whether any of the women received mammograms outside of the national screening program. It’s a tossup for us to grade and, as we do in most such cases, we’ll give the story the benefit of the doubt. Claim: Mammogram benefits more modest than doctors thought

SOLUTION: However, it does not explain to readers what is new or different about this study compared to earlier reports. Also, the final word in the story goes to an expert who touts benefits of mammography screening that clash with what was seen in this study. By comparing this story with, for example, the Philadelphia Inquirer and WebMD stories, you see how some of the gaps we’ve identified were addressed by competitors, giving readers a more complete and helpful story.

PROBLEM: Paragraph: Pfizer shares were up nearly 4 percent on positive findings for the oral treatment, called palbociclib, one of the company’s most important experimental drugs that some analysts believe could eventually claim annual sales of more than $5 billion, if approved. The trial tested the pill in post-menopausal patients with locally advanced or newly diagnosed breast cancer that had spread to other parts of the body. “We are delighted with the final data,” Pfizer said in a release, adding the company will discuss the successful data on progression-free survival with the U.S. Food and Drug Administration “to determine next steps” for palbociclib. A secondary goal of the study is to determine whether palbociclib can prolong overall survival. But Pfizer spokeswoman Sally Beatty said the company does not yet have such data, because it takes longer periods to follow patients and gauge survival trends. Although Pfizer is conducting two larger late-stage trials of palbociclib, ISI Group analyst Mark Schoenebaum noted the company has previously said it might discuss with the FDA the potential to seek approval of the medicine based upon mid-stage trial data, if the data warranted. Palbociclib, which blocks enzymes known as cyclin-dependent kinases (CDKs) 4 and 6, was taken in combination with a standard treatment called letrozole among women who were estrogen receptor positive - meaning tumors grow in response to estrogen - and HER2-negative, meaning that the HER2 protein is not causing the cancer. Such patients make up about 60 percent of advanced breast cancer cases. Letrozole is the chemical name of Femara, a Novartis AG drug that belongs to a class of treatments called aromatase inhibitors that block production of estrogen. Pfizer on Monday did not present detailed data from the trial results, saying they would be presented at a scientific meeting in San Diego in April. The success of the trial, called Paloma-1, follows highly favorable interim data that Pfizer unveiled in December 2012. At that point in the study, those taking both palbociclib and letrozole went an average of 26.1 months before tumors worsened. That compared with 7.5 months for those taking letrozole, but not palbociclib. The 18.6-month difference was considered statistically significant. Side effects from palbociclib were similar to those previously reported, Pfizer said on Monday. The earlier interim results had shown that patients taking the drug combination experienced anemia, fatigue and neutropenia - a decline in white blood cells called neutrophils that can put patients at higher risk of infection. Palbociclib was designated a “breakthrough” drug by the FDA last April based on initial data from the trial. The FDA grants “breakthrough” status to drugs that may offer substantial improvement over existing treatments for serious or life-threatening diseases. The status helps to speed up the approval process. Pfizer has started two late-stage trials of the drug - Paloma-2 and Paloma-3 - in patients with advanced breast cancer. Paloma-2 will test the same drug combination, palbociclib and letrozole, as an initial treatment for breast cancer. Paloma-3 will evaluate palbociclib in combination with another hormone therapy, fulvestrant, in women whose cancer has progressed after hormonal therapy. The drug, sold under the brand name Faslodex by AstraZeneca Plc, is called an estrogen receptor antagonist. Companies trying to develop treatments similar to palbociclib include Novartis and Eli Lilly & Co. Breast cancer killed more than 508,000 women worldwide in 2011, according to the World Health Organization. Pfizer shares were up 3.7 percent at $31.53 on Monday morning on the New York Stock Exchange. Claim: Pfizer breast cancer drug succeeds in mid-stage trial.

SOLUTION: Pfizer Inc’s experimental breast cancer drug significantly delayed progression of symptoms in a mid-stage trial, meeting the study’s primary goal and keeping Pfizer in the forefront of a race for a new standard of care for the disease.

PROBLEM: Paragraph: Hahn, a cancer specialist and hospital executive, won confirmation to the role of FDA commissioner with a vote of 72-18. The move comes as key decisions about regulating electronic cigarettes, including how to keep them away from teenagers, remain unresolved. More than three months ago President Donald Trump and his top health officials said they would soon sweep virtually all flavored e-cigarettes from the market because of their appeal to children and teens. But that effort has stalled after vaping lobbyists pushed back and White House advisers told Trump the ban could cost him votes with adults who vape. In his confirmation hearing last month, Hahn repeatedly sidestepped questions about the fate of the flavor ban. When lawmakers tried to pin down his preferred approach to regulating vaping, Hahn said only that he would follow the “science and evidence.”  Still, he won the backing of several key vaping critics in the Senate, including Illinois Democrat Dick Durbin, who said he hoped Hahn would use his influence to push the Trump administration to crack down on the industry. “Dr. Hahn said to me he doesn’t want to be known in history as the head of the FDA who saw this epidemic grow dramatically,” said Durbin, speaking on the Senate floor Wednesday. Durbin, the No. 2 Democrat in the Senate, supports legislation that would place new taxes on e-cigarettes and restrict flavors with the aim of discouraging underage use. Anti-vaping groups and health experts argue that flavors like fruit, mint, menthol and others attract underage teens. But vaping proponents say flavors can help adult smokers switch to vaping from cigarettes, which cause cancer, lung disease, stroke and other deadly diseases. Underage vaping has reached what health officials call epidemic levels. In the latest government survey, 1 in 4 high school students reported using e-cigarettes in the previous month, despite federal law banning sales to those under 18. More than a third of U.S. states have already raised their sales age for e-cigarettes and other tobacco products to 21. E-cigarettes typically heat a solution that contains nicotine, which makes cigarettes and e-cigarettes addictive. They are generally considered less harmful than paper-and-tobacco cigarettes, though there is little research on their long-term health effects. Hahn, 59, will succeed Dr. Scott Gottlieb, who left the federal agency in April. Gottlieb bucked expectations early in his tenure by announcing an unprecedented effort to curb smoking. Under the plan outlined in July 2017, the FDA would use its authority to cut nicotine in cigarettes to non-addictive levels, encouraging smokers to quit or switch to less harmful products, such as e-cigarettes. The proposal for cutting nicotine was targeted for release in October this year, according to the agency’s regulatory agenda. But it didn’t appear and was dropped last month from the FDA’s updated list of regulatory priorities. An FDA spokeswoman said the agency is continuing to review the policy. But anti-tobacco advocates worry the Trump administration is backing away from its earlier commitment to making cigarettes less addictive. The FDA regulates a broad array of consumer goods and medicine — everything from new drugs and medical devices to packaged food, nutrition labeling, tobacco and cosmetics. As FDA commissioner, Hahn will face a raft of other pressing health issues, including dealing with the prescription opioid epidemic, safety problems with imported drugs and the regulation of CBD, a marijuana derivative that has become a trendy food additive. Hahn, who specializes in treating lung cancer, most recently worked as the top medical executive at MD Anderson Cancer Center in Houston. ___ Follow Matthew Perrone on Twitter: @AP_FDAwriter ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. Claim: Senate OKs Trump’s FDA nominee despite unclear vaping agenda.

SOLUTION:
The Senate on Thursday confirmed Dr. Stephen Hahn to lead the Food and Drug Administration despite concerns about how he will confront the growing problem of underage vaping.